Immunogenicity and safety of Haemophilus influenzae type b polysaccharide-Neisseria meningitidis conjugate vaccine in 7.5 micrograms liquid formulation: a comparison of three lots with the 15.0 micrograms lyophilized formulation. Study Group for 7.5 micrograms Liquid PedvaxHIB.
We conducted a multicenter, single-blind, randomized comparisons of the immunogenicity and safety of three manufacturing-scale lots of 7.5 micrograms liquid Haemophilus influenzae type b polysaccharide- Neisseria meningitidis conjugate vaccine (PRP-OMPC) and a single lot of 15.0 micrograms lyophilized PRP OMPC. A total of 908 infants were entered into the study. Each infant received two primary injections intramuscularly 2 months apart beginning at age 2-6 months and a booster injection at 12-15 months. Blood samples for serology were obtained before each injection and 1 month after the second and the booster dose. Immune responses were measured by radioimmunoassay. Approximately 80% of the infants achieved a titer > 1.0 micrograms ml-1 after the second primary dose of all four lots tested: the geometric mean titer (GMT) was ca 3 micrograms ml-1 for each vaccine group. After the booster dose, more than 90% of infants from each vaccine group had a titer > 1.0 microgram ml-1;GMTs ranged from 8 to 10 micrograms ml-1. No serious vaccine-associated adverse reactions were reported. Thus the 7.5 liquid PRP OMPC vaccine was at least as immunogenic and well tolerated as the 15.0 micrograms lyophilized vaccine.
Mendelman
P M
PM
Merck Research Laboratories, Blue Bell, PA 19422, USA.
Feeley
L
L
Bird
S
S
Staub
T
T
Matthews
H
H
Del Beccaro
M A
MA
Overturf
G
G
Lee
A
A
Ellis
R
R
Staub
J
J
Szymanski
S
S
Donnelly
J
J
Hennessey
J P
JP
Kniskern
P
P
D001425:Bacterial Outer Membrane Proteins / Q000009:adverse effects / Q000276:immunology*; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D005612:Freeze Drying; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007223:Infant; D009345:Neisseria meningitidis / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology*; D016037:Single-Blind Method; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology*
D001425:Bacterial Outer Membrane Proteins; D004304:Dosage Forms; D018073:Haemophilus Vaccines; C061964:Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate