Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Meningococcal
Intervention: MenC-TT (Biological); Hib-MenC-TT (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and
reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C
polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK
Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different
formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant
vaccines were given to all children to complete the vaccination agenda.
Clinical Details
Official title: Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups
Secondary outcome: Prior to dose 1, 1 m post doses 2, 3: anti-PRPPrior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN Solicited (days [d] 0-7), unsolicited (up to 30 d) adverse events (AEs) after each dose Serious adverse events (SAEs)
Detailed description:
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT
vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations
double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood
samples taken, before dose 1 and one month after dose 2 and dose 3.
Eligibility
Minimum age: 8 Weeks.
Maximum age: 16 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male or female infants, 8 to 16 weeks of age at the time of the first
vaccination.
Exclusion Criteria:
- Previous vaccination against OR history of OR exposure since birth to diphtheria,
pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine not foreseen in the study since
birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures, allergic disease or reactions likely
to be exacerbated by any component of the vaccine
Locations and Contacts
Additional Information
Starting date: March 2002
Last updated: July 20, 2015
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