Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004799

Enrollment

10000

Registered

2000-02-25

Start date

1991-04-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis

Keywords

bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease

Brief summary

OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden. II. Compare the relative protection of each vaccine against atypical or subclinical pertussis infection. III. Analyze possible laboratory correlates to vaccine protection.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT) and filamentous hemagglutin (FHA). The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and agglutinogen 3. The third group receives a whole-cell pertussis vaccine. The fourth group receives a diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age. Close surveillance of infants and families continues for 2-3 years.

Interventions

BIOLOGICALwhole-cell pertussis vaccine

BIOLOGICALdiphtheria-tetanus vaccine

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Months to 3 Months

Healthy volunteers

Yes

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Population Characteristics-- * Infants aged 2 months at planned date of first vaccination * No prior pertussis confirmed by culture * The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination --Patient Characteristics-- * Age: Under 3 months * Renal: No renal failure * Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026