Table 1.
Summary of Efficacy Results From Selected Pertussis Vaccine Trials Conducted in the 1990s
| Study Site (Reference[s]), Manufacturer (Location) | Study Characteristics |
Vaccine Characteristics |
||||
|---|---|---|---|---|---|---|
| Design | Vaccination Schedule, Age, mo. | Primary Case Definition | Antigen(s) | Postvaccine Follow-upa,e | Efficacy, % (95% CI) | |
| Italy [15, 16] | Prospective, randomized, double blind, placebo controlled | 2, 4, 6 | ≥21 d of paroxysmal cough, with culture- or serologically confirmed B. pertussis infection | … | … | … |
| Chiron Biocine (Italy) | … | … | … | PT, FHA, PRN | 17 mo | 84 (76–90) |
| … | … | … | … | 26 mob | 89 (79–94) | |
| SmithKline Beecham (Belgium) | … | … | … | PT, FHA, PRN | 17 mo | 84 (76–89) |
| … | … | … | … | 26 mob | 78 (62–87) | |
| Connaught Laboratories (United States) | … | … | … | Pertussis whole cell | 17 mo | 36 (14–52) |
| Sweden [18] | Prospective, randomized, double blind, placebo controlled | 2, 4, 6 | ≥21 d of paroxysmal cough, with culture- or serologically confirmed pertussis or documented contact with an infected household member who has culture-confirmed pertussis | … | … | … |
| Smithkine Beecham (Belgium) | … | … | … | PT, FHA | 21–23.5 mo | 59 (51–66) |
| Connaught Laboratories (Canada) | … | … | … | PT, FHA, FIM2, FIM3, PRN | 21–23.5 mo | 85 (81–89) |
| Connaught Laboratories (United States) | … | … | … | Pertussis whole cell | 21–23.5 mo | 48 (37–58) |
| Senegal [21] | Prospective, randomized, double blind, nested contact | 2, 4, 6 | ≥21 d of paroxysmal cough, with culture- or serologically confirmed pertussis or direct epidemiological linkage to a culture-confirmed pertussis case | … | … | … |
| Pasteur Mérieux Sérums and Vaccines (France) | … | … | … | PT, FHA | 1.7–1.8 y | 85 (66–93) |
| Pasteur Mérieux Sérums and Vaccines (France) | … | … | … | Pertussis whole cell | 1.7–1.8 y | 96 (86–99) |
| Germany [22] | Prospective, blinded, household-contact study | 3, 4, 5 | ≥21 d of paroxysmal cough, with culture- or serologically confirmed pertussisc | … | … | … |
| SmithKline Beecham (Belgium) | … | … | … | PT, FHA, PRN | 2 y | 89 (77–95) |
| SmithKline Beecham (Belgium) | … | … | … | Pertussis whole cell | 2 y | 98 (83–100) |
| Sweden [19] | Prospective, randomized, double blind | 3, 5, 12; 2, 4, 6d | ≥21 d of paroxysmal cough, with culture-confirmed pertussis | … | … | … |
| RR of Pertussis With Cough (95% CI) | ||||||
| SmithKline Beecham (Belgium) | … | … | … | PT, FHA | Not donef | |
| Chiron Vaccines (Italy) | … | … | … | PT, FHA, PRN | 1.4 (.7–2.7) | |
| Pasteur-Merieux-Connaught, (Canada) | … | … | … | PT, FHA, PRN, FIM2, FIM3 | 0.85 (.4–1.8) | |
| Evans Medical (United Kingdom) | … | … | … | Pertussis whole cell | 1.0 | |
The table is adapted from contents in the article by Halperin [8].
Abbreviations: CI, confidence interval; FHA, filamentous hemagglutinin; FIM2, type 2 fimbriae; FIM3, type 3 fimbriae; PRN, pertactin; PT, pertussis toxoid; RR, relative risk.
a Data are duration of follow-up after the last dose, which composed the period examined in the efficacy analysis.
b After the 17-month follow-up period was completed (stage I), eligible children were followed for an additional 9 months (stage II).
c Children presenting with ≥21 days of spasmodic cough with either culture or serological confirmation of B. pertussis infection were considered index cases. Vaccine efficacy was measured in nonvaccinated household contacts.
d An independent analysis was not done in infants enrolled in the 2-, 4-, 6-month vaccination schedule.
e Post vaccine follow up period [19] was 3 years.
f Assignment of infants randomized to the 2-component acellular vaccine was made known during the trial because of poor efficacy.