Last updated: 11/03/2018 09:47:43

Study to evaluate the safety and immunogenicity of a 10-valent pneumococcal conjugate vaccine in preterm infants

GSK study ID
107737
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study to assess the safety and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine when Co-administered with DTPa-HBV-IPV/Hib (Infanrix-Hexa) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
Trial description: This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with core fever (rectal temperature) greater than (>) the cut-off

Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

Number of subjects with any and Grade 3 solicited general symptoms

Timeframe: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

Number of subjects with any serious adverse events (SAEs)

Timeframe: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).

Number of subjects with any serious adverse events (SAEs)

Timeframe: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).

Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F greater than or equal to (≥) the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with concentrations of antibodies against protein D (Anti-PD) ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Concentrations of antibodies against protein D (Anti-PD)

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-diphtheria (Anti DT) and anti-tetanus toxoids (Anti TT) antibody concentrations ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Antibody concentrations for anti-diphtheria and tetanus toxoids ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations ≥ th cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Antibody concentration for anti-pertussis toxoid (anti-PT) , anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-Hepatitis B surface antigen (HBs) antibody concentrations ≥ the cut-off.

Timeframe: One month after the 3rd vaccine dose (Month 5)

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with anti-polio type 1, 2 and 3 antibody titres

Timeframe: One month after the 3rd vaccine dose (Month 5)

Antibody titers for polio type 1, 2 and 3 ≥ the cut-off

Timeframe: One month after the 3rd vaccine dose (Month 5)

Number of subjects with vaccine response to anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN)

Timeframe: One month after the 3rd vaccine dose (Month 5)

Interventions:
Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
Biological/vaccine: Infanrix hexa
Enrollment:
286
Observational study model:
Not applicable
Primary completion date:
2007-02-07
Time perspective:
Not applicable
Clinical publications:
Omenaca F et al. (2011) Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 128(2):e290-e298.
Omeneca F et al. Vaccination of pre-term infants with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Omeneca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.
Omenaca F et al. (2011) Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 128(2):290-298.
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
October 2006 to May 2008
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
8 - 16 weeks
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Thessaloniki, Greece, 54636
Status
Study Complete
Location
GSK Investigational Site
Ioannina, Greece, 452 21
Status
Study Complete
Location
GSK Investigational Site
Burgos, Spain, 09005
Status
Study Complete
Location
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
Status
Study Complete
Location
GSK Investigational Site
Athens, Greece, 115 27
Status
Study Complete
Location
GSK Investigational Site
Madrid, Spain, 28047
Status
Study Complete
Location
GSK Investigational Site
Rio/Patras, Greece, 26500
Status
Study Complete

Study documents

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

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2007-02-07
Actual study completion date
2008-02-05

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

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