Vaccine Information: PENTACEL (Page 4 of 5)

14.4 Poliomyelitis

In Study P3T06 (Table 1), in which infants were randomized to receive the first three doses of Pentacel or DAPTACEL + IPOL + ActHIB at 2, 4, and 6 months of age, one month following the third dose of study vaccines, ≥99.4% of participants in both groups (Pentacel: N = 338-350), (DAPTACEL + IPOL + ActHIB: N = 1,050-1,097) achieved neutralizing antibody levels of ≥1:8 for Poliovirus types 1, 2, and 3.

In Study 494-01 (Table 1), in which infants were randomized to receive Pentacel or HCPDT + POLIOVAX + ActHIB, GMTs (1/dil) of antibodies to Poliovirus types 1, 2, and 3 one month following Dose 4 of Pentacel (N = 851-857) were 2,304, 4,178, and 4,415, respectively, and one month following Dose 4 of POLIOVAX (N = 284-287) were 2,330, 2,840, and 3,300, respectively.

14.5 Invasive Disease due to H. Influenzae Type b

Anti-PRP seroprotection rates and GMCs one month following Dose 3 of Pentacel or separately administered ActHIB in studies 494-01, P3T06, and M5A10 are presented in Table 6. In Study 494-01, non-inferiority criteria were not met for the proportion of participants who achieved an anti-PRP level ≥1.0 mcg/mL and for anti-PRP GMCs following Pentacel compared with separately administered ActHIB. In each of Studies P3T06 and M5A10, the non-inferiority criterion was met for the proportion of participants who achieved an anti-PRP level ≥1.0 mcg/mL following Pentacel compared with separately administered ActHIB. In Study M5A10, the non-inferiority criterion was met for anti-PRP GMCs following Pentacel compared with separately administered ActHIB.

Table 6: Anti-PRP Seroprotection Rates and GMCs One Month Following Three Doses of Pentacel or Separate DTaP + IPV + ActHIB Administered at 2, 4, and 6 Months of Age in Studies 494-01, P3T06, and M5A10
Per Protocol Immunogenicity population for all studies.IPV indicates Poliovirus Vaccine Inactivated.
*
Percent achieving specified level following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 90% CI for difference in rates (ActHIB minus Pentacel) <10%].
Non-inferiority criterion not met for percent achieving anti-PRP ≥1.0 mcg/mL following Pentacel vaccine relative to ActHIB vaccine [upper limit of 90% CI for difference in rates (ActHIB minus Pentacel), 12.9%, exceeds the non-inferiority criterion <10%].
Non-inferiority criterion not met for GMC following Pentacel vaccine relative to ActHIB vaccine [upper limit of 90% CI of GMC ratio (ActHIB/Pentacel), 2.26, exceeds the non-inferiority criterion <1.5].
§
Non-inferiority criterion not pre-specified.
Percent achieving specified level following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 95% CI for difference in rates (ActHIB minus Pentacel) <10%].
#
GMC following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 90% CI of GMC ratio (ActHIB/Pentacel) <1.5].
Study 494-01
PentacelN = 1,127 HCPDT + POLIOVAX + ActHIBN = 401
% achieving anti-PRP ≥0.15 mcg/mL 95.4* 98.3
% achieving anti-PRP ≥1.0 mcg/mL 79.1 88.8
Anti-PRP GMC (mcg/mL) 3.19 6.23
Study P3T06
PentacelN = 365 DAPTACEL + IPOL + ActHIBN = 1,128
% achieving anti-PRP ≥0.15 mcg/mL 92.3* 93.3
% achieving anti-PRP ≥1.0 mcg/mL 72.1* 70.8
Anti-PRP GMC (mcg/mL) 2.31§ 2.29
Study M5A10
PentacelN = 826 DAPTACEL + IPOL + ActHIBN = 421
% achieving anti-PRP ≥0.15 mcg/mL 93.8 90.3
% achieving anti-PRP ≥1.0 mcg/mL 75.1 74.8
Anti-PRP GMC (mcg/mL) 2.52# 2.38

In Study 494-01, at 15 months of age prior to receipt of Dose 4 of study vaccines, 68.6% of Pentacel recipients (N = 829) and 80.8% of separately administered ActHIB recipients (N = 276) had an anti-PRP level ≥0.15 mcg/mL. Following Dose 4 of study vaccines, 98.2% of Pentacel recipients (N = 874) and 99.0% of separately administered ActHIB recipients (N = 291) had an anti-PRP level ≥1.0 mcg/mL.

In Study P3T06, at 15 months of age prior to receipt of Dose 4 of study vaccines, 65.4% of Pentacel recipients (N = 335) and 60.7% of separately administered ActHIB recipients (N = 323) had an anti-PRP level ≥0.15 mcg/mL. Following Dose 4 of study vaccines, 97.8% of Pentacel recipients (N = 361) and 95.9% of separately administered ActHIB recipients (N = 340) had an anti-PRP level ≥1.0 mcg/mL.

14.6 Concomitantly Administered Vaccines

In Study P3T06, (Table 1) there was no evidence for reduced antibody responses to hepatitis B vaccine (percent of participants with anti-HBsAg ≥10 mIU/mL and GMCs) or PCV7 (percent of participants with antibody levels ≥0.15 mcg/mL and ≥0.5 mcg/mL and GMCs to each serotype) administered concomitantly with Pentacel (N = 321-325) relative to these vaccines administered concomitantly with DAPTACEL + IPOL + ActHIB (N = 998-1,029). The immune responses to hepatitis B vaccine and PCV7 were evaluated one month following the third dose.

In Study 494-03, (Table 1) there was no evidence for interference in the immune response to the fourth dose of PCV7 (percent of participants with antibody levels ≥0.15 mcg/mL and ≥0.5 mcg/mL and GMCs to each serotype) administered at 15 months of age concomitantly with Pentacel (N = 155) relative to this vaccine administered concomitantly with MMR and varicella vaccines (N = 158). There was no evidence for interference in the immune response to MMR and varicella vaccines (percent of participants with pre-specified seroresponse level) administered at 15 months of age concomitantly with Pentacel (N = 154) relative to these vaccines administered concomitantly with PCV7 (N = 144). The immune responses to MMR, varicella vaccine and the fourth dose of PCV7 were evaluated one month post-vaccination.

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