Last updated: 11/21/2020 12:10:13

Impact on carriage, acute otitis media, immuno & safety of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A

Request patient level data
GSK study ID
112595
See study documents
Clinicaltrials.gov ID
NCT00839254
See results summary
EudraCT ID
2008-006551-51
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A
Trial description: The aim of this study is to assess the effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.
The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Secondary outcomes:

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of probable culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months).

Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in reducing hospital-diagnosed pneumonia with Chest X-ray (CXR) reading according to WHO criteria- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in prevention of all tympanostomy tube placements- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in prevention of all antimicrobial prescriptions- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months.

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 7-11 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 12-18 months schedule.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months.

Number of subjects classified by antimicrobial susceptiblity of IPD isolates in children starting vaccination within 7 months of life and assigned to a 2 or 3-dose primary vaccination course

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – mean FU time=24 months.

Number of subjects with Lower respiratory tract infections (LRTIs) (in a subset of subjects in Turku area )

Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).

Number of subjects with Upper respiratory tract infections (URTIs) (in a subset of subjects in Turku area )

Timeframe: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months).

Number of subjects with any and Grade 3 solicited local symptoms.

Timeframe: Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)

Number of subjects with any, Grade 3 and related solicited general symptoms.

Timeframe: Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects)

Number of subjects with any unsolicited adverse events (AEs).

Timeframe: Within 31 days (31D) after each vaccination (M0+31D, M1+31D [only for 3+1 schedule], M2+31D, M8+31D [booster dose] for 6W-6M subjects; M0+31D, M2+31D, M6+31D [booster dose] for 7M-11M subjects; M0+31D, M6+31D for 12M-18M subjects)

Number of subjects with serious adverse events (SAEs).

Timeframe: Following administration of the first vaccine dose up to study end (M0 up to M18 for subjects aged 6W to 6M at enrollment; M0 up to M16 for subjects aged 7M to 11M at enrollment; M0 up to M9 for subjects aged 12M to 18M at enrollment)

Number of subjects enrolled and vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 study with post-study SAEs reported via passive surveillance– Subjects enrolled aged 6 weeks to 6 months and 7 to 18 months

Timeframe: From the end of the blinded ID Follow-Up period (at least 30 months from the study start) up to the end of 18-month period after study unblinding

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster) at 23-27 mths of age (10 mths post-booster)

NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

ANTIBODY CONCENTRATIONS AGAINST PROTEIN D (ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

ANTIBODY CONCENTRATIONS AGAINST PROTEIN D(ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN

Timeframe: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster)

PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2)

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN

Timeframe: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012).

Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course till end of LT FU period.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).

Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course till end of LT FU period.

Timeframe: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months).

Interventions:
  • Biological/vaccine: Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
  • Biological/vaccine: GSK Biologicals’ Engerix TM vaccine (Hepatitis B vaccine)
  • Biological/vaccine: GSK Biologicals’ Havrix TM vaccine (Hepatitis A vaccine)
    • Enrollment:
    6181
    Primary completion date:
    2012-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Vesikari T et al. (2016) Effectiveness of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D-Conjugated Vaccine (PHiD-CV) Against Carriage and Acute Otitis Media-A Double-Blind Randomized Clinical Trial in Finland. J Pediatric Infect Dis Soc. [Epub ahead of print]
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A, SB208109, SKF103860
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to January 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 weeks - 18 months
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
    • Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.
    • Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.

      • Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
      • Written informed consent obtained from parent(s) or from the guardian(s) of the subject.
    Exclusion criteria:

      Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.

      • Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
      • Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
      • Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
      • Known severe hypersensitivity to any component of the study vaccines, including neomycin.
      • Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Espoo, Finland, 02100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Helsinki, Finland, 00100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Helsinki, Finland, 00930
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jarvenpaa, Finland, 04400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kokkola, Finland, 67100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kotka, Finland, 48600
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 15 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-31-01
    Actual study completion date
    2012-31-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website