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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-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)

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

Page last updated: August 20, 2015

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