Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Diphtheria
Tetanus
Acellular Pertussis

Treatments

Biological: SB213503 lot 3
Biological: IPOL
Biological: Infanrix
Biological: SB213503 lot 1
Biological: SB213503 lot 2
Biological: M-M-R II

Study type

Interventional

Funder types

Industry

Identifiers

NCT00148941
213503/048

Details and patient eligibility

About

The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.

Full description

Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine. Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections. Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit. A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Enrollment

4,209 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female child between and including 4 and 6 years of age at the time of vaccination.
  • Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study.
  • Received 4 doses of Infanrix and 3 doses of IPOL during the first 2 years of life.
  • Vaccination against measles, mumps, and rubella in the second year of life.
  • Subjects whom the investigator believed would comply with the requirements of the protocol.
  • Written informed consent obtained before study entry from the parent(s) or guardian(s) of the subject.

Exclusion criteria

  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
  • History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life.
  • Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
  • Poliovirus vaccination with one or more doses of OPV vaccine.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
  • Chronic administration or administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
  • Administration of immunoglobulins and/or any blood products within three months prior to study vaccination or planned administration during the study period ending at Day 30.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrollment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
  • History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
  • Encephalopathy within 7 days of administration of previous dose of Infanrix.
  • Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix not due to another identifiable cause.
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of previous dose of Infanrix.
  • Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred within 48 hours of administration of previous dose of Infanrix.
  • Thrombocytopenia following a previous dose of M-M-RII or its component vaccines.
  • Inability to contact a parent/guardian of the subject by telephone.
  • Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject was demonstrated.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,209 participants in 4 patient groups

SB213503 lot 1 + M-M-R Group
Experimental group
Description:
Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Treatment:
Biological: M-M-R II
Biological: SB213503 lot 1
SB213503 lot 2 + M-M-R Group
Experimental group
Description:
Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Treatment:
Biological: M-M-R II
Biological: SB213503 lot 2
SB213503 lot 3 + M-M-R Group
Experimental group
Description:
Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Treatment:
Biological: M-M-R II
Biological: SB213503 lot 3
Infanrix + IPOL + M-M-R Group
Active Comparator group
Description:
Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
Treatment:
Biological: M-M-R II
Biological: Infanrix
Biological: IPOL

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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