Among 58 children previously given a primary course of PedvaxHIB, 90% (95% C.I. 78.8%, 96.1%) developed an anti-PRP response > 1 mcg/mL with a GMT of 9.6 mcg/mL (95% C.I. 6.6, 14.1) in response to a dose of COMVAX at 12-15 months of age. Among 683 children previously given a primary course of another HIB or HIB-containing vaccine, 99% (95% C.I. 97.9%, 99.6%) developed an anti-PRP response > 1 mcg/mL with a GMT of 14.9 mcg/mL (95% C.I. 13.7, 16.3) in response to a dose of COMVAX at 12-15 months of age.

In another study, COMVAX was administered either concomitantly or six weeks after vaccination with M-M-R* II and VARIVAX* (Varicella Virus Vaccine Live, Oka/Merck). Among 149 children who previously received 2 doses of monovalent Hepatitis B vaccine, 100% (95% C.I. 97.6%, 100.0%) developed an anti-HBs response ≥ 10 mIU/mL with a GMT of 2194.6 mIU/mL (95% C.I. 1667.8, 2887.8) in response to a dose of COMVAX at 12-15 months of age.

Antibody Responses to COMVAX and Concurrently Administered Vaccines

Immunogenicity results from open-labeled studies indicate that COMVAX can be administered concomitantly with DTP, DTaP, OPV, IPV (inactivated poliomyelitis vaccine), M-M-R II, and VARIVAX using separate sites and syringes for injectable vaccines.

DTP and DTaP

After a primary series of DTP (2, 4, 6 months of age) given concomitantly with COMVAX (2 and 4 months of age), 98.2% of 57 infants developed a 4-fold rise in antibody to diphtheria, 100% of 57 infants developed a 4-fold rise in antibody to tetanus, and 89.5% to 96.5% of 57 infants developed a 4-fold rise in antibody to pertussis antigens, depending on the assay used and adjusted for maternal antibody. In this trial, after 2 doses of COMVAX, 79.0% of 62 infants developed anti-PRP > 1.0 mcg/mL and after 3 doses (2, 4, and 15 months of age), 100% of 59 infants developed ≥ 10 mIU/mL of anti-HBs.

After a primary series of DTaP and COMVAX given concomitantly at 2, 4, and 6 months of age, 100% of 18 infants had ≥ 0.01 antitoxin units/mL to diphtheria and tetanus and 94.4% to 100% of 18 infants developed a ≥ 4-fold rise in antibody to pertussis antigens, depending on the assay used and adjusted for maternal antibody. In this trial, after 2 doses of COMVAX, 85.7% of 63 infants developed anti-PRP > 1.0 mcg/mL and after 3 doses administered on the compressed schedule of 2, 4, and 6 months of age, 92.9% of 56 infants developed ≥ 10 mIU/mL of anti-HBs.

OPV and IPV

After a primary series of OPV (2, 4, 6 months of age) given concomitantly with COMVAX (2 and 4 months of age), 98.3% of 60 infants had neutralizing antibody ≥ 1:4 to poliovirus type 1, 100% of 57 infants had neutralizing antibody ≥ 1:4 to poliovirus type 2 and 98.1% of 53 infants had neutralizing antibody ≥ 1:4 to poliovirus type 3. In this trial, after 2 doses of COMVAX, 79.0% of 62 infants developed anti-PRP > 1.0 mcg/mL and after 3 doses, 100% of 59 infants developed ≥ 10 mIU/mL of anti-HBs.

After a primary series of IPV and COMVAX given concomitantly at 2, 4, and 6 months of age, 100% of 38 infants had neutralizing antibody ≥ 1:4 to poliovirus types 1, 2, and 3. In this trial, after 2 doses of COMVAX, 85.7% of 63 infants developed anti-PRP > 1.0 mcg/mL and after 3 doses administered on the compressed schedule of 2, 4, and 6 months of age, 92.9% of 56 infants developed ≥ 10 mIU/mL of anti-HBs.

M-M-R II and VARIVAX

After concomitant vaccination of M-M-R II and VARIVAX with COMVAX (12 to 15 months of age), 99.4% of 313 children developed antibody to measles, 99.2% of 354 children developed antibody to mumps, 100% of 358 children developed antibody to rubella and 100% of 276 children developed antibody to varicella. In this trial, infants received the primary series of Hib vaccine and the first two doses of Hepatitis B vaccine in the first year of life. After the dose of COMVAX, 97.8% of 368 infants developed > 1.0 mcg/mL of anti-PRP and 99.2% developed ≥ 10 mIU/mL of anti-HBs.

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