Bacterial Infections, Virus Diseases
Conditions
Keywords
Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection
Brief summary
This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.
Interventions
BIOLOGICALPrevnar 13™
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
BIOLOGICALRotaTeq™
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
BIOLOGICALPENTACEL™
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
BIOLOGICALRecombivax HB vaccine
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
BIOLOGICALActHIB™
ActHIB™ 0.5 mL intramuscular injection at 15 months of age
BIOLOGICALPedvaxHIB™
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
BIOLOGICALV419
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, 4, and 6 months of age
BIOLOGICALDAPTACEL™
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
Sponsors
MCM Vaccines B.V.
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
: * Participant is a healthy infant * Participant has received one dose of monovalent hepatitis B vaccine prior to or at 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, or any combination of the above * Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment * Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment * Participant 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. |
| Percentage of Participants Responding to Poliovirus Type 1 | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Poliovirus Type 2 | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Poliovirus Type 3 | Postdose 3 (Month 7) | 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. |
| Geometric Mean Concentration of Antibodies to Pertussis Toxin | Postdose 3 (Month 7) | 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). |
| Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. |
| Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. |
| Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Hepatitis B Surface Antigen | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Diphtheria Toxin | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Tetanus Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL. |
| Percentage of Participants Responding to Pertussis Toxin | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Pertussis Pertactin | Postdose 3 (Month 7) | 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. |
| Percentage of Participants Responding to Pertussis Fimbriae | Postdose 3 (Month 7) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus. |
| Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Up to 5 days after any infant vaccination (up to 6 months) | Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \>5 cm. Grade 3 Solicited systemic reactions: Pyrexia, \>=39.5°C (\>=103.1°F) rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable. |
| Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Up to 5 days after any infant vaccination (up to 6 months) | Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator. |
| Percentage of Participants With Elevated Temperature by Severity | Up to 5 days after any infant vaccination (up to 6 months) | Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \>=38.0°C. |
| Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Up to 15 days after any infant vaccination (up to 6 months) | The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported. |
| Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. |
Participant flow
Pre-assignment details
The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.
Participants by arm
| Arm | Count |
|---|---|
| V419 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. | 986 |
| Control Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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. | 487 |
| Total | 1,473 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Infant Series | Adverse Event | 1 | 1 |
| Infant Series | Death | 1 | 1 |
| Infant Series | Lost to Follow-up | 13 | 7 |
| Infant Series | Non-compliance with study drug | 2 | 1 |
| Infant Series | Physician Decision | 3 | 1 |
| Infant Series | Protocol Violation | 22 | 9 |
| Infant Series | Randomized but not vaccinated | 5 | 3 |
| Infant Series | Withdrawal by Subject | 15 | 4 |
| Interim Period | Lost to Follow-up | 51 | 23 |
| Interim Period | Non-compliance with study drug | 1 | 0 |
| Interim Period | Other protocol criterion not met | 0 | 1 |
| Interim Period | Physician Decision | 6 | 3 |
| Interim Period | Protocol Violation | 5 | 3 |
| Interim Period | Withdrawal by Subject | 18 | 10 |
| Toddler Vaccinations | Lost to Follow-up | 11 | 12 |
| Toddler Vaccinations | Protocol Violation | 0 | 1 |
| Toddler Vaccinations | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | V419 | Control | Total |
|---|---|---|---|
| Age, Continuous | 65.6 Days STANDARD_DEVIATION 7.5 | 65.0 Days STANDARD_DEVIATION 6.9 | 65.4 Days STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 479 Participants | 214 Participants | 693 Participants |
| Sex: Female, Male Male | 507 Participants | 273 Participants | 780 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 939 / 980 | 458 / 483 |
| serious Total, serious adverse events | 58 / 980 | 32 / 483 |
Outcome results
Primary
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 48.17 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 74.44 EU/mL |
p-value: 0.78695% CI: [0.59, 0.7]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 88.92 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 89.18 EU/mL |
p-value: <0.00195% CI: [0.91, 1.1]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 235.62 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 185.54 EU/mL |
p-value: <0.00195% CI: [1.15, 1.42]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 658.50 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 414.66 EU/mL |
p-value: <0.00195% CI: [1.41, 1.78]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 108.05 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 139.35 EU/mL |
p-value: 0.01495% CI: [0.68, 0.89]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 56.22 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 66.16 EU/mL |
p-value: <0.00195% CI: [0.73, 0.95]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Toxin
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).
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 110.40 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 86.54 EU/mL |
p-value: <0.00195% CI: [1.2, 1.38]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 127.22 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 91.31 EU/mL |
p-value: <0.00195% CI: [1.28, 1.52]ANCOVA
Primary
Percentage of Participants Responding to Diphtheria Toxin
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Diphtheria Toxin | 82.44 Percentage of participants |
| Control | Percentage of Participants Responding to Diphtheria Toxin | 86.26 Percentage of participants |
p-value: 0.00295% CI: [-8.02, 0.66]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Hepatitis B Surface Antigen
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Hepatitis B Surface Antigen | 99.42 Percentage of participants |
| Control | Percentage of Participants Responding to Hepatitis B Surface Antigen | 98.58 Percentage of participants |
p-value: <0.00195% CI: [-0.35, 2.74]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 87.31 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 92.07 Percentage of participants |
p-value: 0.00195% CI: [-8.14, -0.97]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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 \<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.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 94.42 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 93.14 Percentage of participants |
p-value: <0.00195% CI: [-1.67, 4.78]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Fimbriae
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 \<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.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Fimbriae | 97.29 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Fimbriae | 91.17 Percentage of participants |
p-value: <0.00195% CI: [3.26, 9.78]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Fimbriae
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Fimbriae | 90.20 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Fimbriae | 86.19 Percentage of participants |
p-value: <0.00195% CI: [0.23, 8.28]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Pertactin
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Pertactin | 79.35 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Pertactin | 82.05 Percentage of participants |
p-value: <0.00195% CI: [-7.27, 2.23]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Pertactin
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 \<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.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Pertactin | 93.01 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Pertactin | 93.45 Percentage of participants |
p-value: <0.00195% CI: [-3.46, 3.1]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Toxin
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Toxin | 98.12 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Toxin | 98.47 Percentage of participants |
p-value: <0.00195% CI: [-1.8, 1.6]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Pertussis Toxin
Participant serum samples were collected for testing with an 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.
Time frame: Postdose 4 (Month 16)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Pertussis Toxin | 99.29 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Toxin | 97.42 Percentage of participants |
p-value: <0.00195% CI: [0.39, 4.18]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Poliovirus Type 1
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Poliovirus Type 1 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 1 | 98.24 Percentage of participants |
p-value: <0.00195% CI: [0.85, 3.59]Miettinen and Nurminen
p-value: <0.00195% CI: [99.54, 100]Clopper and Pearson
Primary
Percentage of Participants Responding to Poliovirus Type 2
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 2 | 99.75 Percentage of participants |
p-value: <0.00195% CI: [-0.22, 1.42]Miettinen and Nurminen
p-value: <0.00195% CI: [99.54, 100]Clopper and Pearson
Primary
Percentage of Participants Responding to Poliovirus Type 3
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Poliovirus Type 3 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 3 | 99.75 Percentage of participants |
p-value: <0.00195% CI: [-0.24, 1.41]Miettinen and Nurminen
p-value: <0.00195% CI: [99.53, 100]Clopper and Pearson
Primary
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
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.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1.0 μg/mL | 84.97 Percentage of participants |
| V419 | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 μg/mL | 97.25 Percentage of participants |
| Control | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1.0 μg/mL | 75.39 Percentage of participants |
| Control | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 μg/mL | 92.41 Percentage of participants |
Comparison: Non-inferiority for titer \>=1.0 μg/mLp-value: <0.00195% CI: [4.83, 14.83]Miettinen and Nurminen
Comparison: Non-inferiority for titer \>=0.15 μg/mLp-value: <0.00195% CI: [2.23, 8.14]Miettinen and Nurminen
Comparison: Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mLp-value: <0.00195% CI: [2.23, 8.14]Miettinen and Nurminen
Primary
Percentage of Participants Responding to Tetanus Toxin
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V419 | Percentage of Participants Responding to Tetanus Toxin | 99.87 Percentage of participants |
| Control | Percentage of Participants Responding to Tetanus Toxin | 99.49 Percentage of participants |
p-value: <0.00195% CI: [-0.28, 1.74]Miettinen and Nurminen
Secondary
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 5.11 μg/mL |
| Control | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 3.18 μg/mL |
p-value: <0.00195% CI: [1.32, 1.98]ANCOVA
Secondary
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
Time frame: Postdose 3 (Month 7)
Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V419 | Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus | 278.19 units/mL |
| Control | Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus | 274.46 units/mL |
p-value: <0.00195% CI: [0.83, 1.24]ANCOVA
Secondary
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia | 45.1 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting | 20.8 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal | 71.4 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability | 79.6 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence | 68.5 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite | 45.7 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite | 40.2 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia | 32.1 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence | 66.7 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting | 16.4 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability | 77.4 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal | 68.5 Percentage of participants |
Secondary
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after each infant vaccination (up to 6 months)
Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 1 | 16.1 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 1 | 11.2 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 3 (N=924, 460) | 8.0 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 1 | 50.9 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 2 (N=950, 472) | 48.4 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 3 (N=924, 460) | 42.0 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 1 | 54.6 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 2 (N=950, 472) | 42.9 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 3 (N=924, 460) | 38.3 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 1 | 27.4 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 2 (N=950, 472) | 24.1 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 3 (N=924, 460) | 20.9 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 1 | 63.2 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 2 (N=950, 472) | 56.6 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 3 (N=924, 460) | 52.7 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 2 (N=950, 472) | 26.6 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 3 (N=924, 460) | 26.6 Percentage of participants |
| V419 | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 2 (N=950, 472) | 10.2 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 3 (N=924, 460) | 35.0 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 1 | 12.6 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 3 (N=924, 460) | 16.2 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 1 | 7.9 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 2 (N=950, 472) | 8.5 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 1 | 24.0 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any vomiting, vaccination 3 (N=924, 460) | 4.6 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 2 (N=950, 472) | 52.7 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 1 | 48.7 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 2 (N=950, 472) | 19.8 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 2 (N=950, 472) | 42.9 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any pyrexia, vaccination 2 (N=950, 472) | 16.4 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any crying abnormal, vaccination 3 (N=924, 460) | 36.1 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any decreased appetite, vaccination 3 (N=924, 460) | 17.3 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 1 | 54.0 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 3 (N=924, 460) | 48.8 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any somnolence, vaccination 2 (N=950, 472) | 41.4 Percentage of participants |
| Control | Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug | Any irritability, vaccination 1 | 60.5 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \>5 cm. Grade 3 Solicited systemic reactions: Pyrexia, \>=39.5°C (\>=103.1°F) rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Population: Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site pain | 73.4 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site pain | 5.9 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 pyrexia | 1.5 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 crying abnormal | 7.9 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any somnolence | 74.1 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any decreased appetite | 48.9 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 decreased appetite | 1.3 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any irritability | 83.1 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 irritability | 7.7 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site erythema | 48.8 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site erythema | 0.2 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site swelling | 40.1 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site swelling | 0.3 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any pyrexia | 47.4 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any vomiting | 25.7 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 vomiting | 0.4 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any crying abnormal | 74.8 Percentage of participants |
| V419 | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 somnolence | 3.5 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any pyrexia | 34.4 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site pain | 71.8 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site erythema | 42.2 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site pain | 4.6 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 irritability | 5.8 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 pyrexia | 1.2 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site erythema | 0.6 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 crying abnormal | 8.3 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any vomiting | 21.5 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any somnolence | 71.6 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 somnolence | 2.9 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site swelling | 34.8 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any decreased appetite | 43.3 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any crying abnormal | 72.3 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 decreased appetite | 0.4 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 injection-site swelling | 0.4 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any irritability | 81.8 Percentage of participants |
| Control | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Grade 3 vomiting | 0.6 Percentage of participants |
Secondary
Percentage of Participants With Elevated Temperature by Severity
Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \>=38.0°C.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants With Elevated Temperature by Severity | All routes <38.0°C | 51.1 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.0°C and <38.5°C, mild | 24.2 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.5°C and <39.5°C, moderate | 22.7 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | All routes >=39.5°C, severe | 2.0 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | Rectal <38.0°C | 44.5 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.0°C and <38.5°C, mild | 24.3 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.5°C and <39.5°C, moderate | 21.6 Percentage of participants |
| V419 | Percentage of Participants With Elevated Temperature by Severity | Rectal >=39.5°C, severe | 2.0 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | Rectal >=39.5°C, severe | 0.9 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | All routes <38.0°C | 64.3 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | Rectal <38.0°C | 57.7 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.0°C and <38.5°C, mild | 19.1 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.5°C and <39.5°C, moderate | 14.9 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.5°C and <39.5°C, moderate | 15.5 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.0°C and <38.5°C, mild | 17.9 Percentage of participants |
| Control | Percentage of Participants With Elevated Temperature by Severity | All routes >=39.5°C, severe | 1.1 Percentage of participants |
Comparison: Estimated difference, all routes \<38°C95% CI: [-18.4, -7.7]
Comparison: Estimated difference, all routes \>=38°C and \<38.5°C95% CI: [0.5, 9.5]
Comparison: Estimated difference, all routes \>=38.5°C and \<39.5°C95% CI: [2.8, 11.2]
Comparison: Estimated difference, all routes \>=39.5°C95% CI: [-0.6, 2.2]
Comparison: Estimated difference, rectal \<38°C95% CI: [-18.6, -7.7]
Comparison: Estimated difference, rectal \>=38°C and \<38.5°C95% CI: [1.9, 10.8]
Comparison: Estimated difference, rectal \>=38.5°C and \<39.5°C95% CI: [2.4, 10.7]
Comparison: Estimated difference, rectal \>=39.5°C95% CI: [-0.3, 2.4]
Secondary
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Time frame: Up to 181 days after any infant vaccination (up to 12 months)
Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion vaccine-related SAEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia SAEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion SAEs | 0.2 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion SAEs | 0.1 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion vaccine-related SAEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia vaccine-related SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion vaccine-related SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion vaccine-related SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion SAEs | 0.4 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia SAEs | 0.2 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia vaccine-related SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion SAEs | 0 Percentage of participants |
Secondary
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Time frame: Up to 15 days after any infant vaccination (up to 6 months)
Population: Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion AEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion AEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia SAEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion SAEs | 0 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia AEs | 49.3 Percentage of participants |
| V419 | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia AEs | 35.6 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion AEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Febrile convulsion SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion AEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Convulsion SAEs | 0 Percentage of participants |
| Control | Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion | Pyrexia SAEs | 0 Percentage of participants |