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

NCT ID: NCT00352963

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2004-07-16

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.

Conditions

Poliomyelitis; Tetanus; Acellular Pertussis; Hepatitis B; Diphtheria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec

Intervention Type: BIOLOGICAL

Eligibility 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.

• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Alcorcón, , Spain

GSK Investigational Site

Almeira, , Spain

GSK Investigational Site

Badalona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Bilbao, , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Córdoba, , Spain

GSK Investigational Site

Getafe, , Spain

GSK Investigational Site

Leganés, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marid, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Móstoles/Madrid, , Spain

GSK Investigational Site

Palma de Mallorca, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valladolid, , Spain

GSK Investigational Site

Vélez-Málaga, , Spain

Countries

Spain

References

Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-del-Rio M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Jacquet JM, Collard A, Schuerman L; Spanish DTaP-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B vaccine coadministered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2006 Aug;25(8):713-20. doi: 10.1097/01.inf.0000227725.61495.c4.

Reference Type: BACKGROUND

PMID: 16874171 (View on PubMed)

Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gomez-Campdera JA, Navarro ML, Merino JM, Martin-Ancel A, Roca J, Garcia-Del-Ri M, Jurado A, Diez-Delgado FJ, Omenaca F, Garcia-Sicilia J, Boceta R, Garcia-Corbeira P, Collard A, Boutriau D, Schuerman L, Jacquet JM; Spanish DTPa-HBV-IPV-097 Study Group. Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months. Pediatr Infect Dis J. 2007 Jan;26(1):1-7. doi: 10.1097/01.inf.0000247070.60063.09.

Reference Type: BACKGROUND

PMID: 17195697 (View on PubMed)

Jeanne Jaquet et al. Co-administration of DTPa-HBV-IPV/Hib with two doses of a MenC-TT conjugate vaccine in primary vaccination - 23rd Annual Meeting ESPID, Valencia, Spain, 18-20 May 2005.

Reference Type: BACKGROUND

Tejedor et al. Immunogenicity and reactogenicity of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C-tetanus toxoid conjugate (Hib-MenC-TT) Vaccine co-administered with a pentavalent DTPa-HBV-IPV vaccine at 2, 4 and 6 months - 24th Annual Meeting ESPID, Basel, Switzerland, 03-05 May 2006.

Reference Type: BACKGROUND

Tozzi AE, Azzari C, Bartolozzi G, Esposito S, Fara GM, Giudice ML. Can hexavalent vaccines be simultaneously administered with pneumococcal or meningococcal conjugate vaccines? Hum Vaccin. 2007 Nov-Dec;3(6):252-9. doi: 10.4161/hv.4626. Epub 2007 Jun 23.

Reference Type: BACKGROUND

PMID: 17881905 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

217744/097

Identifier Type: -

Identifier Source: org_study_id