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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00352963
First received: July 14, 2006
Last updated: July 22, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Prophylaxis of DTPa-HBV-IPV-Hib & MenC Diseases
 Biological: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity & Safety Study of GSK Biologicals' Hib-MenC+Infanrix Penta™ Vaccines and NeisVac-C (Meningitis C Vaccine;Baxter)+GSK's Infanrix Hexa™ vs. Meningitec™ (Men. C Vaccine;Wyeth)+Infanrix Hexa™ in Healthy Infants (2,4,6 M).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • At M7: Antibodies to PRP, MenC HBsAg

Secondary Outcome Measures:
  • At M7: Abs. to all vaccine antigens
  • At M6: Abs. to PRP & MenC
  • Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

Estimated Enrollment: 480
Intervention Details:
    Biological: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
    Other Name: Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352963

Locations
Spain
GSK Investigational Site
Alcorcon, Spain, 28922
GSK Investigational Site
Almeira, Spain, 4009
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08950
GSK Investigational Site
Bilbao, Spain, 48013
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Cordoba, Spain, 14004
GSK Investigational Site
Getafe, Spain, 28905
GSK Investigational Site
Leganes, Spain
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Valladolid, Spain, 47010
GSK Investigational Site
Velez, Malaga, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00352963     History of Changes
Other Study ID Numbers: 217744/097
Study First Received: July 14, 2006
Last Updated: July 22, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by GlaxoSmithKline:
Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered

ClinicalTrials.gov processed this record on May 19, 2013