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

NCT00352963 | Completed Phase 3

• 1 other identifier: 217744/097
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 22

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

Keywords

Open, phase 3, Infanrix hexa™, Hib-MenC, co-administered

Outcome Measures

Primary Outcomes (1)

• At M7: Antibodies to PRP, MenC HBsAg

Secondary Outcomes (3)

• At M7: Abs. to all vaccine antigens

• At M6: Abs. to PRP & MenC

• Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

Interventions

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

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained from the parent/guardian of the subject.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Alcorcón, 28922, Spain

Location

GSK Investigational Site

Almeira, 4009, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08950, Spain

Location

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Getafe, 28905, Spain

Location

GSK Investigational Site

Leganés, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07014, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

GSK Investigational Site

Valladolid, 47010, Spain

Location

GSK Investigational Site

Vélez-Málaga, Spain

Location

Related Publications (5)

• 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.

  PMID: 16874171 BACKGROUND

• 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.

  PMID: 17195697 BACKGROUND

• 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.

  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.

  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.

  PMID: 17881905 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Poliomyelitis; Tetanus; Hepatitis B; Diphtheria

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Corynebacterium Infections; Actinomycetales Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: September 30, 2003
• Study Completion: July 16, 2004
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

ES (22)