Phase 3 Completed N=2,808 Randomized Quadruple-blind Prevention

A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

Bacterial Infections · Virus Diseases

Source: ClinicalTrials.gov NCT01340937 ↗

Enrolled (actual)

2,808

Serious AEs

3.9%

Results posted

May 2016

Primary outcomePrimary: Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen — 5.51; 6.10; 6.59; 3.76 µg/mL — p=<0.001

Summary

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	5.51; 6.10; 6.59; 3.76; 6.05	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen	1195.96; 1376.86; 1414.52; 609.08	—
PRIMARY Geometric Mean Concentration of Antibodies to Diphtheria Toxin	0.37; 0.36; 0.38; 0.40	—
PRIMARY Geometric Mean Concentration of Antibodies to Tetanus Toxin	1.59; 1.63; 1.55; 0.89	—
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Toxin	110.61; 102.82; 110.41; 110.62; 110.79	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	106.30; 121.00; 101.81; 104.70; 112.60	<0.001 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Pertactin	104.51; 142.32; 94.26; 108.69; 111.42	0.035 sig
PRIMARY Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	451.04; 337.79; 409.37; 475.65; 471.52	<0.001 sig
PRIMARY Geometric Mean Titer for Antibodies to Poliovirus Type 1	579.77; 684.68; 666.18; 269.95	—
PRIMARY Geometric Mean Titer for Antibodies to Poliovirus Type 2	1212.40; 1276.56; 1359.78; 846.14	—
PRIMARY Geometric Mean Titer for Antibodies to Poliovirus Type 3	901.70; 851.34; 825.31; 784.24	—
SECONDARY Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	86.75; 87.25; 88.40; 79.51; 87.47; 99.01	<0.001 sig
SECONDARY Percentage of Participants Responding to Hepatitis B Surface Antigen	99.66; 100.00; 100.00; 98.95; 99.89	<0.001 sig
SECONDARY Percentage of Participants Responding to Diphtheria Toxin	85.05; 84.80; 86.41; 87.71; 85.42	<0.001 sig
SECONDARY Percentage of Participants Responding to Tetanus Toxin	99.84; 100.00; 100.00; 98.67; 99.95	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Toxin	98.51; 98.43; 99.25; 98.12; 98.18	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	95.33; 95.40; 96.06; 94.36; 95.54	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Pertactin	92.16; 91.09; 91.28; 92.08; 93.14	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Fimbriae	92.97; 90.15; 91.91; 94.17; 92.84	<0.001 sig
SECONDARY Percentage of Participants Responding to Poliovirus Type 1	100.00; 100.00; 100.00; 99.35; 100.00	<0.001 sig
SECONDARY Percentage of Participants Responding to Poliovirus Type 2	100.00; 100.00; 100.00; 100.00; 100.00	<0.001 sig
SECONDARY Percentage of Participants Responding to Poliovirus Type 3	100.00; 100.00; 100.00; 99.67; 100.00	<0.001 sig
SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Toxin	110.61; 102.82; 110.41; 110.62; 110.79	<0.001 sig
SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	106.30; 121.00; 101.81; 104.70; 112.60	<0.001 sig
SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Pertactin	104.51; 142.32; 94.26; 108.69; 111.42	0.035 sig
SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	451.04; 337.79; 409.37; 475.65; 471.52	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Toxin	98.51; 98.43; 99.25; 98.12; 98.18	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	95.33; 95.40; 96.06; 94.36; 95.54	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Pertactin	92.16; 91.09; 91.28; 92.08; 93.14	<0.001 sig
SECONDARY Percentage of Participants Responding to Pertussis Fimbriae	92.97; 90.15; 91.91; 94.17; 92.84	<0.001 sig
SECONDARY Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes	1.44; 1.55; 1.47; 1.40; 1.44; 0.48	<0.001 sig
SECONDARY Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions	40.8; 44.6; 0.8; 0.3; 72.0; 70.0	—
SECONDARY Percentage of Participants With Elevated Temperature by Severity	50.8; 64.6; 27.2; 23.3; 19.5; 10.8	—

Eligibility Criteria

Inclusion Criteria

Participant is a healthy infant
Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age

Exclusion Criteria

Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines or any combination of the above
Participant has had an illness with fever within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01340937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.