Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01341639 | Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) | PHASE3 | COMPLETED | 1,250 | — | — | May 26, 2011 | Mar 13, 2013 | Apr 30, 2019 | - | — |
| NCT01340937 | A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) | PHASE3 | COMPLETED | 2,808 | — | — | May 10, 2011 | Jul 26, 2013 | Nov 15, 2018 | - | — |
| NCT01337167 | Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) | PHASE3 | COMPLETED | 1,473 | — | — | Apr 19, 2011 | May 9, 2013 | Nov 15, 2018 | - | — |
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%).
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer \>=0.15 μg/mL and \>=1.0 μg/mL.
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 milli International units (mIU)/mL.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 International unit (IU)/mL.
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \>=8.
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \>=8.
| Arm | Type | Description |
|---|---|---|
| PR5I | EXPERIMENTAL | V419 + RotaTeq + Prevenar 13 + ProQuad |
| INFANRIX™ hexa | ACTIVE_COMPARATOR | INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad |
| V419 Lot A | EXPERIMENTAL | V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
| V419 Lot B | EXPERIMENTAL | V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
| V419 Lot C | EXPERIMENTAL | V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
| Control | ACTIVE_COMPARATOR | Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age |
| V419 | EXPERIMENTAL | V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| V419 | BIOLOGICAL | V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and Hepatitis B \[Recombinant\] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age. |
| INFANRIX™ hexa | BIOLOGICAL | INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age. |
| RotaTeq | BIOLOGICAL | RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age |
| Prevenar 13 | BIOLOGICAL | Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age |
| ProQuad™ | BIOLOGICAL | ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age |
| PENTACEL™ | BIOLOGICAL | PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group |
| Prevnar 13™ | BIOLOGICAL | Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age |
| RotaTeq™ | BIOLOGICAL | RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
| Recombivax HB vaccine | BIOLOGICAL | Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age |
| DAPTACEL™ | BIOLOGICAL | DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age |
| PedvaxHIB™ | BIOLOGICAL | PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age |
| ActHIB™ | BIOLOGICAL | ActHIB™ 0.5 mL intramuscular injection at 15 months of age |
Inclusion Criteria * Healthy infants able to attend all study visits * Parent(s)/legal representative able to read, understand, and complete study questionnaires Exclusion Criteria * History of congenital or acquired immunodeficiency * Received or is expected to receive immunosuppressive agents o...