Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

Phase 3

Completed

• Conditions: Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis; Hepatitis B

• Registration Number: NCT00352963
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-30
• Study Completion: 2004-07-16
• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
• Written informed consent obtained from the parent/guardian of the subject.

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Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
• Administration of immunosuppressants or other immune-modifying drugs from birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
At M7: Antibodies to PRP, MenC HBsAg

Secondary Outcome Measures

Name	Time	Method
At M6: Abs. to PRP & MenC
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)
At M7: Abs. to all vaccine antigens

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Velez, Malaga, Spain