Last updated: 11/07/2018 05:23:52

Consistency & immunogenicity study of 3 lots of GSK's Hib conjugate vaccine versus ActHIB & Pentacel in healthy infantsN/A

GSK study ID
112957
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: Phase III, partially double-blind study to evaluate consistency and immunogenicity of 3 lots of GSK Biologicals' Hib conjugate vaccine 208108 versus ActHIB and Pentacel at 2, 4, 6 and 15-18 months of age in healthy infants
Trial description: The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals’ Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Allocation:
Randomized
Primary outcomes:

Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL) and ≥ 1.0 µg/mL

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-Protein-D (anti-D) and anti-Protein-T (anti-T) antibody concentrations ≥ 0.1 International Units per milliliter (IU/mL)

Timeframe: At 1 month after last dose of primary vaccination

Anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations

Timeframe: At 1 month after last dose of primary vaccination

Anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA) antibody concentrations

Timeframe: At 1 month after last dose of primary vaccination

Anti-Streptococcus pneumoniae (S.pneumoniae) antibody concentrations

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with seroresponse (95%) to anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA)

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-Polio 1,2,3 antibody titres greater than or equal to cut-off value

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations ≥ 1.0 µg/mL

Timeframe: At 1 month after booster vaccination

Secondary outcomes:

Anti-protein-D (anti-D) and anti-protein-T (anti-T) antibody concentrations

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with any solicited local symptoms

Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination

Number of subjects with any solicited general symptoms

Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination

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

Timeframe: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination

Number of subjects with serious adverse events (SAEs)

Timeframe: From Day 0 until 6 months following the last primary dose

Number of subjects with AEs of specific interest (AESIs)

Timeframe: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first

Number of subjects with seroresponse (90%) to anti-PT, anti-PRN and anti-FHA

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-PT, anti-PRN and anti-FHA antibody concentrations ≥ 5 EL.U/mL

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Anti-Hepatitis B (Anti-HBs) antibody concentrations

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with S.pneumoniae antibody concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL

Timeframe: At 1 month after the last dose of primary vaccination

Antibody titers for Poliovirus types 1, 2 and 3

Timeframe: At 1 month after last dose of primary vaccination

Number of subjects with anti-HBs antibody concentrations greater than or equal to cut-off values

Timeframe: At 1 month after last dose of primary vaccination

Anti-polyribosylribitol phosphate (PRP) antibody concentrations

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Anti-Hepatitis B (Anti-HBs) antibody concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL

Timeframe: Prior to the booster vaccination

Number of subjects with anti-HB antibody concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL

Timeframe: Prior to booster vaccination

Number of subjects with Anti-PT, anti-FHA and anti-PRN concentrations ≥ 5 EL.U/mL

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Anti-poliovirus types 1, 2, and 3 antibody titres and titres ≥ 8

Timeframe: Prior to the booster vaccination

Number of subjects with anti-Polio-1,2,3 antibody titers ≥ 8

Timeframe: Prior to booster vaccination

Number of subjects with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, respectively.

Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination

Number of subjects with any solicited local symptoms

Timeframe: Within 4 days (Days 0-3) following the booster dose

Number of subjects with any solicited general symptoms

Timeframe: Within 4 days (Days 0-3) following the booster dose

Number of subjects with AEs of specific interest (AESIs)

Timeframe: From booster dose until 6 months following receipt of the booster dose

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

Timeframe: Within 31 days (Day 0 to Day 30) following the booster dose

Number of subjects with serious adverse events (SAEs)

Timeframe: From the booster dose until 6 months following receipt of the booster dose

Anti-FHA, Anti-PRN and Anti-PT antibody concentrations

Timeframe: pre-booster and one month after booster vaccination

Interventions:
Biological/vaccine: GSK Biologicals’ Haemophilus influenzae type b vaccine (GSK 208108)
Biological/vaccine: ActHIB™
Biological/vaccine: Pentacel™
Biological/vaccine: Pediarix™
Biological/vaccine: Prevnar 13™
Biological/vaccine: Rotarix™
Biological/vaccine: Engerix™-B
Biological/vaccine: Infanrix™
Enrollment:
4003
Observational study model:
Not applicable
Primary completion date:
2011-18-11
Time perspective:
Not applicable
Clinical publications:
Nicola P et al. (2017) Lot-to-lot consistency, safety and immunogenicity of 3 lots of Haemophilus influenzae type b conjugate vaccine: results from a phase III randomized, multicenter study in infants. Vaccine. 35(28):3564-3574.
Medical condition
Haemophilus influenzae type b
Product
SB208108, SB208355, SB217744, SB444563, SKF103860
Collaborators
Not applicable
Study date(s)
June 2010 to July 2013
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
  • Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bountiful, Utah, United States, 84010
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93726
Status
Study Complete
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96819
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vallejo, California, United States, 94589
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92804
Status
Study Complete
Location
GSK Investigational Site
Amarillo, Texas, United States, 79124
Status
Study Complete
Location
GSK Investigational Site
Santa Clara, California, United States, 95051
Status
Study Complete
Location
GSK Investigational Site
Tulsa, Oklahoma, United States, 74107
Status
Study Complete
Location
GSK Investigational Site
Daly City, California, United States, 94015
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Utica, New York, United States, 13502
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Mineola, New York, United States, 11501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Fremont, California, United States, 94538
Status
Study Complete
Location
GSK Investigational Site
Hermitage, Pennsylvania, United States, 16148
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Antioch, California, United States, 94509
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76107
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Study Complete
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68131
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
Status
Study Complete
Location
GSK Investigational Site
South Jordon, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95815
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Redwood City, California, United States, 94063
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
Roy, Utah, United States, 84067
Status
Study Complete
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sugarland, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Syracuse, Utah, United States, 84075
Status
Study Complete
Location
GSK Investigational Site
Waipio, Hawaii, United States, 96797
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95119
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Dayton, Ohio, United States, 45406
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Dothan, Alabama, United States, 36305
Status
Study Complete
Location
GSK Investigational Site
Benton, Arkansas, United States, 72019
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44121
Status
Study Complete
Location
GSK Investigational Site
Fall River, Massachusetts, United States, 02721
Status
Study Complete
Location
GSK Investigational Site
Layton, Utah, United States, 84041
Status
Study Complete
Location
GSK Investigational Site
Orange City, Florida, United States, 32763
Status
Study Complete
Location
GSK Investigational Site
Canton, Ohio, United States, 44718
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Study Complete
Location
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80922
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Hayward, California, United States, 94545
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77055
Status
Study Complete
Location
GSK Investigational Site
Nampa, Idaho, United States, 83686
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
2011-18-11
Actual study completion date
2013-17-07

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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