In clinical trials involving the administration of 7918 doses of COMVAX to 3561 healthy infants 6 weeks to 15 months of age, COMVAX was generally well tolerated. In these studies, infants received COMVAX with licensed pediatric vaccines (n=1745) or investigational vaccines (n=1816). Serious adverse experience data were available for all 3561 infants and non-serious adverse experience data were available for a subset of 1678 infants. Pivotal Immunogenicity And Safety Study In the pivotal, randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either COMVAX or PedvaxHIB plus RECOMBIVAX HB at separate injection sites at 2, 4, and 12-15 months of age. Children may have also received routine pediatric immunizations. The children were monitored daily for five days after each injection for injection-site and systemic adverse experiences. During this time, adverse experiences in infants who received COMVAX were generally similar in type and frequency to those observed in infants who received PedvaxHIB plus RECOMBIVAX HB. The most frequently cited events were mild, transient signs and symptoms of inflammation at the injection site (i.e., pain/soreness, erythema, and swelling/induration), somnolence, and irritability, all of which were prompted for on report cards filled out by parents of vaccinated children. Table 3 summarizes the frequencies of injection-site and systemic adverse experiences within five days of vaccination that were reported among ≥ 1.0% of children in this pivotal trial. Table 3 : Local Reactions and Systemic Complaints Within 5 Days After Injection Reported to Occur in ≥ 1.0%t of Children Given a 3-Dose Course of COMVAX Compared to These Events in Children Given Concomitant Injections of PedvaxHIB and RECOMBIVAX HB
Event Injection 1‡ Injection 2‡ Injection 3 COMVAX
(N=660)% PedvaxHIB and RECOMBIVAX HB***
(N=645)% PedvaxHIB and RECOMBIVAX HB***
(N=593)% PedvaxHIB and RECOMBIVAX HB***
(N=193)% Injection Site Reactions Pain/Soreness* 34.5 37.6 24.3 25.8 23.9 21.2 Erythema ( > 1 in.)* 22.4 (2.7) 25.8 (2.7) 25.7 (1.4) 23.5 (3.3) 27.2 (3.0) 24.4 (1.6) Swelling/Induration ( > 1 in.)* 27.6 (3.0) 33.5 (4.1) 30.4 (2.9) 31.0 (3.8) 27.2 (3.2) 29.5 (4.1) Systemic Complaints Irritability* 57.0 46.6 50.7 44.1 32.2 29.0 Somnolence* 49.5 47.1 37.4 31.9 21.1 22.3 Crying unusual, high pitched* 10.6 8.6 6.7 2.3 2.9 3.6 not otherwise specified 2.3 2.3 1.4 2.3 0.7 1.6 prolonged ( > 4 hrs.)* 2.4 2.3 0.8 1.4 0.2 0 Anorexia 3.9 2.3 2.0 0.9 0.8 0.5 Vomiting 2.1 1.8 2.5 0.9 1.0 1.6 Otitis media 0.5 0 2.0 1.4 2.7 1.6 Fever (°F, rectal equiv.)** 101.0-102.9 14.2 11.9 13.8 12.2 10.5 6.4 ≥ 103.0 0.8 0 1.6 1.4 2.7 4.3 Diarrhea 1.7 1.8 0.8 0.9 2.2 0.5 Upper respiratory infection 0.5 0.5 1.1 0.9 1.3 0.5 Rash 0.8 0 0.9 0 0.8 0.5 Rhinorrhea 0.2 0 1.1 0.9 1.3 2.1 Respiratory congestion 0.6 0.5 1.2 0.9 0.3 0.5 Cough 0.2 0 0.9 0.5 0.2 1.0 Candidiasis, oral 0.3 0.5 0.8 0 0.2 0 Rash, diaper 0.5 0.5 0.5 0.9 0.2 0 † Overall frequency of each event listed above is ≥ 1% even though the frequency after a given dose may be < 1%.
‡ Most children received DTP and OPV concomitantly with the first two doses of COMVAX or PedvaxHIB and RECOMBIVAX HB.
* Events prompted for on Vaccination Report Card given to parents/guardians of vaccinees.
** N for injections 1, 2, and 3 equals 655, 639, and 588, respectively, for COMVAX; N for injections 1, 2, and 3 equals 218, 213, and 187, respectively, for PedvaxHIB and RECOMBIVAX HB.
*** Injection site reactions for PedvaxHIB and RECOMBIVAX HB based on occurrence with either of the monovalent components. Infants Previously Vaccinated With Hepatitis B Vaccine In a group of infants (N=126) given a three-dose course of COMVAX after previously receiving a dose of Hepatitis B Vaccine (Recombinant) at or shortly after birth, the type, frequency, and severity of adverse experiences did not appear to be greater than those observed in infants in the pivotal study who did not receive hepatitis B vaccine at birth. Infants 6 Weeks To 15 Months Of Age In clinical trials, 3285 doses of COMVAX were administered to 1678 infants who were monitored for injection-site and systemic adverse experiences from Days 0 to 5 after each injection of vaccine. Of these, 855 infants had safety data following vaccination at approximately 2 months of age, 836 infants at approximately 4 months of age and 1573 infants at 12 to 15 months of age. The most frequently reported adverse experiences ( ≥ 1% of subjects for at least one injection), without regard to causality are listed in decreasing order of frequency within each body system: Injection Site Reactions: Pain/tenderness/soreness, swelling/induration, erythema; Body as a Whole: Fever; Digestive System: Anorexia, diarrhea, vomiting; Nervous System/Psychiatric: Irritability, somnolence, crying; Respiratory System: Upper respiratory infection, rhinorrhea, cough, rhinitis; Skin: Rash; Special Senses: Otitis media. Post-Marketing Experience As with any vaccine, there is the possibility that broad use of COMVAX could reveal adverse experiences not observed in clinical trials. The following additional adverse reactions have been reported with the use of the marketed vaccine. Hypersensitivity Anaphylaxis, angioedema, urticaria, erythema multiforme Hematologic Thrombocytopenia Nervous System Seizure, febrile seizures Potential Adverse Effects In addition, a variety of adverse effects have been reported with marketed use of either PedvaxHIB or RECOMBIVAX HB in infants and children through 71 months of age. These adverse effects are listed below. PedvaxHIB Hematologic/Lymphatic Lymphadenopathy Skin Sterile injection-site abscess; pain at the injection site RECOMBIVAX HB Hypersensitivity Symptoms of hypersensitivity including reports of rash, pruritus, edema, arthralgia, dyspnea, hypotension, and ecchymoses Cardiovascular System Tachycardia; syncope Digestive System Elevation of liver enzymes Hematologic Increased erythrocyte sedimentation rate Musculoskeletal System Arthritis Nervous System Bell's Palsy; Guillain-Barre Syndrome Psychiatric/Behavioral Agitation; somnolence; irritability Skin Stevens-Johnson Syndrome; alopecia Special Senses Conjunctivitis; visual disturbances Adverse Event Reporting Patients, parents and guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967. The healthcare provider should inform the parent or guardian of the National Vaccine Injury Compensation Program (NVICP), 1-800-338-2382. Read the Comvax (haemophilus b conjugate and hepatitis b vaccine) Side Effects Center for a complete guide to possible side effectsLearn More »