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
Study complete
Study complete
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
    Primary completion date:
    2011-18-11
    Observational study model:
    Not applicable
    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
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    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
    Study complete
    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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    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
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