Table 2.
Selected Solicited Adverse Events Occuring by the Third Evening After Vaccination (at 2, 4, or 6 Months of Age) in the Multicenter Acellular Pertussis Trial [150] and Selected Subsequent Efficacy Trials [129, 130, 131, 175]
| Multicenter Acellular Pertussis Trial | Efficacy Trials | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Vaccine | Temperature >38.4°C |
Redness >20 mm |
Swelling >20 mm |
Paina | Fussinessb | Drowsiness | Anorexia | Crying ≥3 Hours |
HHE | Seizures 1st 48 Hours |
| Whole-cellc | 15.9% | 16.4% | 22.4% | 40.2% | 41.5% | 62.0% | 35.0% | 11.5% | 1.7% | 0.06% |
| Acelluvaxd | 1.6% | 1.6% | 2.4% | 1.6% | 16.7% | 41.3% | 19.0% | 1.3% | 0% | 0% |
| Infanrixe | 3.3% | 4.2% | 5.8% | 10.8% | 15.0% | 46.7% | 19.2% | 1.9% | 0.2% | 0.002% |
| Triavaxf | 4.6% | 4.5% | 5.3% | 8.3% | 12.0% | 42.1% | 20.3% | n/a | n/a | 0.09% |
| Tripacelf | 3.6% | 3.6% | 4.4% | 5.1% | 18.2% | 42.3% | 19.0% | n/a | 0.04% | 0% |
Abbreviations: HHE, hypotonic hyporesponsive episode; n/a, not applicable.
aModerate (cried or protested to touch) or severe (cried when leg moved).
bModerate (prolonged crying and refused to play) or severe (persistent crying and could not be comforted).
cWhole-cell vaccines: MAPT, manufactured by Wyeth-Lederle Vaccines and Pediatrics, USA, no longer available; efficacy trials: manufactured by Connaught Laboratories, USA, no longer available.
dA 3-component vaccine (also known as Triacelluvax) manufactured by Chiron Vaccines that contained 5 mcg of genetically inactivated pertussis toxin (PT) and 2.5 mcg each of filamentous hemagglutinin (FHA) and pertactin (PRN). No longer available.
eA 3-component vaccine manufactured by GlaxoSmithKline, Belgium that contains 25 mcg each of PT and FHA and 8 mcg of PRN. Also available as a component in Boostrix, Infanrix-IPV, Infanrix hexa, Kinrix, Pediarix, etc.
fA 2-component vaccine manufactured by Sanofi Pasteur, France that contains 25 mcg each of PT and FHA (also known as Triaxim). Not available except as a component in Hexaxim, Hexacima, Hexyon, Tetraxim, Pentaxim, etc.
gA 5-component vaccine manufactured by Sanofi Pasteur, Canada. Also available as Daptacel (contains 10 mcg PT, 5 mcg FHA, 3 mcg PRN, and 5 mcg of fimbriae) and (with the PT and FHA increased to 20 mcg each) as a component in Pentacel, PediaceI, Quadracel, Adacel, Adacel-Polio, and in MCM Vaccine Company’s Vaxelis.