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Comvax

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Clinical Pharmacology

Comvax

Two clinical studies assessed antibody responses to a three-dose series of COMVAX in 128 evaluable infants who were previously given a birth dose of hepatitis B vaccine. Table 2 summarizes the anti-PRP and anti-HBs responses of these infants. The antibody responses were clinically comparable to those observed in the pivotal trial of COMVAX (Table 1).

Table 2
Antibody Responses to COMVAX in Infants Previously Vaccinated with Hepatitis B Vaccine at Birth


Study Age (months)
at Vaccination		 Time n Anti-PRP
% Subjects with
> 0.15 mcg/mL
> 1.0 mcg/mL 		Anti-PRP
GMT
(mcg/mL)		 n Anti-HBs
% Subjects
≥ 10 mIU/mL		 Anti-HBs
GMT
(mIU/mL)
Study 1 [N=126] 2 Prevaccination Dose 1 119 24.4 5.9 0.1 71 25.4 2.9
    Not Measured        
4 Dose 2* 111 94.6 81.1 3.3 111 98.2 417.2
14/15 Dose 3* 88 100 93.2 11.0 0.2 87 15 98.9 6.7 3500.7
Study 2 [N=19]   Prevaccination 17 58.8 0 0.7
2 Dose 1** 17 88.2 47.1 0.9 16 81.3 35.2
4 Dose 2** 17 100 76.5 2.8 16 100 281.8
15 Dose 3** 15 100 100 8.5 16 100 3913.4
* Postvaccination responses were determined approximately 2 months after dose 2 and 1 month after dose 3.
** Postvaccination responses were determined approximately 2 months after doses 1, 2, and 3.Infants in these studies received DTP and OPV or eIPV (enhanced inactivated poliovirus vaccine) concomitantly with the first two doses ofCOMVAX, while the third dose of COMVAX was given concomitantly with DTaP (diphtheria and tetanus and acellular pertussis), OPV, andM-M-R* II at 14-15 months of age (Study 1) or with just M-M-R* II at 15 months of age (Study 2).

Interchangeability of COMVAX and Licensed Haemophilus b Conjugate Vaccines or Recombinant Hepatitis B Vaccines

Brand Name: Comvax
Generic Name: Haemophilus b Conjugate and Hepatitis B Vaccine

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