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

Hepatitis B Clinical Trial

Official title:

Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352963
• Other study ID #: 217744/097
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2003
• Est. completion date: July 16, 2004

Study information

• Verified date: January 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 16, 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Hepatitis B
• Poliomyelitis
• Tetanus

Intervention

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

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Alcorcon
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	Cordoba
Spain	GSK Investigational Site	Getafe
Spain	GSK Investigational Site	Leganes
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Velez, Malaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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.

Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gómez-Campderá JA, Navarro ML, Merino JM, Martín-Ancel A, Roca J, García-Del-Rí M, Jurado A, Díez-Delgado FJ, Omeñaca F, García-Sicilia J, Boceta R, García-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. — View Citation

Tejedor JC, Moro M, Ruiz-Contreras J, Castro J, Gómez-Campderá JA, Navarro ML, Merino JM, Martín-Ancel A, Roca J, García-del-Río M, Jurado A, Díez-Delgado FJ, Omeñaca F, García-Sicilia J, Boceta R, García-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. — View Citation

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. Epub 2007 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At M7: Antibodies to PRP, MenC HBsAg
Secondary	At M7: Abs. to all vaccine antigens
Secondary	At M6: Abs. to PRP & MenC
Secondary	Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

External Links

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