Last updated: 11/03/2018 09:01:38
Primary & booster study in infants to demonstrate non-inferiority, persistence & immunogenicity of Hib-MenC vaccine
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to demonstrate non-inferiority of GSK Biologicals’ Hib-MenC given with Infanrix™ penta versus NeisVac-C™ given with Infanrix™ hexa at 3, 5 months of age and persistence prior to a Hib-MenC booster at 11 months and immunogenicity of the booster
Trial description: The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals’ Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
SBA-MenC titre
Timeframe: One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration
Timeframe: One month after the second dose of the Primary Vaccination Phase
Secondary outcomes:
SBA-MenC titres
Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PRP concentrations
Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Anti-PSC concentrations
Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination.
Anti-HBs concentrations
Timeframe: One month after the second dose of the Primary Vaccination Phase; prior to and one month after the Booster Vaccination
Occurrence of local solicited adverse events.
Timeframe: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of solicited general adverse events
Timeframe: During the solicited follow-up period (Day 0 - Day 3) following the administration of each vaccine dose.
Occurrence of unsolicited non-serious adverse events
Timeframe: Within 30 days after each vaccination
Occurrence of any serious adverse events
Timeframe: Throughout the study.
Interventions:
Biological/vaccine: Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Biological/vaccine: Infanrix Penta
Biological/vaccine: Infanrix hexa
Biological/vaccine: Neis-Vac-C
Enrollment:
709
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Vesikari T et al. (2013) A combined Haemophilus influenza type b-Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: results of an open, randomized, controlled study. Pediatr Infect Dis J. 32(5):521-529.
Medical condition
Neisseria Meningitidis, Haemophilus influenzae type b
Product
SB811936
Collaborators
Not applicable
Study date(s)
April 2006 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Inclusion Criteria
- Primary Phase:
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.
- Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study. Booster Phase:
- Participation in primary phase of study. Exclusion Criteria Primary Phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.
- Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
- History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional Exclusion criteria for the Booster Phase:
- Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).
Inclusion Criteria Primary Phase:
Trial location(s)
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-23-11
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.
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