Study to Evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningitis, Haemophilus |
Biological: MenC-TT Biological: Hib-MenC-TT |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups
- Prior to dose 1, 1 m post doses 2, 3: anti-PRP
- Prior 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)
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2002 |
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| Ages Eligible for Study: | 8 Weeks to 16 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00135486 History of Changes |
| Other Study ID Numbers: | 711202/001 |
| Study First Received: | August 25, 2005 |
| Last Updated: | November 23, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by GlaxoSmithKline:
|
Prophylaxis meningococcal serogroup C disease, Hib diseases Haemophilus Influenzae type b/Meningococcal vaccine |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Haemophilus Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial |
Central Nervous System Bacterial Infections Bacterial Infections Haemophilus Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013