Phase 3
Completed N=2,808
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
◆ Published Evidence
Established
24citations · ~3 / year
Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants.
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™.
Linked Publications
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Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants.
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 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
Data sourced from ClinicalTrials.gov (NCT01340937) and the linked publication. 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.