Bacterial Infections, Virus Diseases
Conditions
Keywords
Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection
Brief 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™.
Detailed description
This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).
Interventions
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) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.
BIOLOGICALPENTACEL™
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
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
BIOLOGICALRecombivax HB vaccine
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
Sponsors
MCM Vaccines B.V.
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Geometric Mean Concentration of Antibodies 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. The unit of measure is milli International Units/mL (mIU/mL). |
| Geometric Mean Concentration of Antibodies 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. The unit of measure is International Units/mL (IU/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 Tetanus Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies. |
| 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 Fimbriae | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. |
| Geometric Mean Titer for Antibodies 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. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity). |
| Geometric Mean Titer for Antibodies 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. |
| Geometric Mean Titer for Antibodies 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Pertussis Toxin | Postdose 4 (Month 16) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control. |
| Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | Postdose 4 (Month 16) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control. |
| Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Postdose 4 (Month 16) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control. |
| 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 a titer \>=0.15 µg/mL and \>=1.0 µg/mL. |
| Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control. |
| 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: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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: Fever (Pyrexia), \>=39.5°C rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable. |
| 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. |
| Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Postdose 4 (Month 16) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control. |
| 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 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 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 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. |
| 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. |
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 Lot A V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 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. | 800 |
| V419 Lot B V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 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. | 797 |
| V419 Lot C V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 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. | 809 |
| Control 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. | 402 |
| Total | 2,808 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1: Infant Series | Adverse Event | 0 | 1 | 4 | 0 |
| Period 1: Infant Series | Death | 2 | 0 | 2 | 0 |
| Period 1: Infant Series | Lost to Follow-up | 20 | 14 | 12 | 13 |
| Period 1: Infant Series | Other protocol criterion not met | 0 | 1 | 1 | 0 |
| Period 1: Infant Series | Physician Decision | 2 | 3 | 1 | 0 |
| Period 1: Infant Series | Protocol Violation | 1 | 4 | 4 | 3 |
| Period 1: Infant Series | Randomized but not vaccinated | 0 | 5 | 2 | 1 |
| Period 1: Infant Series | Withdrawal by Subject | 33 | 32 | 30 | 15 |
| Period 2: Interim Period | Adverse Event | 1 | 0 | 1 | 0 |
| Period 2: Interim Period | Lost to Follow-up | 29 | 48 | 53 | 23 |
| Period 2: Interim Period | Physician Decision | 0 | 1 | 1 | 0 |
| Period 2: Interim Period | Protocol Violation | 5 | 3 | 6 | 3 |
| Period 2: Interim Period | Technical problems | 4 | 4 | 6 | 3 |
| Period 2: Interim Period | Withdrawal by Subject | 28 | 23 | 17 | 12 |
| Period 3: Toddler Vaccinations | Lost to Follow-up | 6 | 14 | 7 | 8 |
| Period 3: Toddler Vaccinations | Protocol Violation | 0 | 0 | 0 | 1 |
| Period 3: Toddler Vaccinations | Technical problem | 1 | 1 | 1 | 0 |
| Period 3: Toddler Vaccinations | Withdrawal by Subject | 2 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | V419 Lot A | V419 Lot B | V419 Lot C | Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.6 Days STANDARD_DEVIATION 6.7 | 64.4 Days STANDARD_DEVIATION 6.2 | 64.7 Days STANDARD_DEVIATION 6.6 | 64.3 Days STANDARD_DEVIATION 6.6 | 64.5 Days STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 377 Participants | 366 Participants | 380 Participants | 215 Participants | 1338 Participants |
| Sex: Female, Male Male | 423 Participants | 431 Participants | 429 Participants | 187 Participants | 1470 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2,259 / 2,390 | 371 / 397 |
| serious Total, serious adverse events | 94 / 2,390 | 15 / 397 |
Outcome results
Primary
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
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).
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 Lot A | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | 0.37 IU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | 0.36 IU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | 0.38 IU/mL |
| Control | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | 0.40 IU/mL |
95% CI: [0.84, 1.07]
95% CI: [0.86, 1.09]
95% CI: [0.9, 1.14]
Primary
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
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).
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 Lot A | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 1195.96 mIU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 1376.86 mIU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 1414.52 mIU/mL |
| Control | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 609.08 mIU/mL |
95% CI: [0.76, 0.98]
95% CI: [0.74, 0.96]
95% CI: [0.86, 1.11]
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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 43.98 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 49.19 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 56.93 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 73.25 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 49.70 EU/mL |
95% CI: [0.83, 0.96]
95% CI: [0.72, 0.83]
95% CI: [0.81, 0.94]
Comparison: Secondary analysisp-value: 0.41995% CI: [0.62, 0.73]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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 228.78 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 286.74 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 283.28 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 175.65 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 264.61 EU/mL |
95% CI: [0.72, 0.85]
95% CI: [0.73, 0.87]
95% CI: [0.93, 1.11]
Comparison: Secondary analysisp-value: <0.00195% CI: [1.37, 1.66]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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 51.30 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 52.32 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 54.78 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 50.96 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 52.76 EU/mL |
95% CI: [0.87, 1.09]
95% CI: [0.83, 1.05]
95% CI: [0.85, 1.08]
Comparison: Secondary analysisp-value: <0.00195% CI: [0.9, 1.17]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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 100.83 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 96.82 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 98.52 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 82.45 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 98.72 EU/mL |
95% CI: [0.96, 1.1]
95% CI: [0.95, 1.09]
95% CI: [0.92, 1.06]
Comparison: Secondary analysisp-value: <0.00195% CI: [1.11, 1.29]ANCOVA
Primary
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 Lot A | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 5.51 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 6.10 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 6.59 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 3.76 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | 6.05 µg/mL |
95% CI: [0.77, 1.08]
95% CI: [0.72, 1.02]
95% CI: [0.79, 1.12]
p-value: <0.00195% CI: [1.35, 1.98]ANCOVA
Primary
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
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 Lot A | Geometric Mean Concentration of Antibodies to Tetanus Toxin | 1.59 IU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Tetanus Toxin | 1.63 IU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Tetanus Toxin | 1.55 IU/mL |
| Control | Geometric Mean Concentration of Antibodies to Tetanus Toxin | 0.89 IU/mL |
95% CI: [0.91, 1.04]
95% CI: [0.95, 1.09]
95% CI: [0.98, 1.13]
Primary
Geometric Mean Titer for Antibodies to Poliovirus Type 1
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).
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 Lot A | Geometric Mean Titer for Antibodies to Poliovirus Type 1 | 579.77 Titer |
| V419 Lot B | Geometric Mean Titer for Antibodies to Poliovirus Type 1 | 684.68 Titer |
| V419 Lot C | Geometric Mean Titer for Antibodies to Poliovirus Type 1 | 666.18 Titer |
| Control | Geometric Mean Titer for Antibodies to Poliovirus Type 1 | 269.95 Titer |
95% CI: [0.76, 0.96]
95% CI: [0.79, 0.99]
95% CI: [0.92, 1.15]
Primary
Geometric Mean Titer for Antibodies to Poliovirus Type 2
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
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 Lot A | Geometric Mean Titer for Antibodies to Poliovirus Type 2 | 1212.40 Titer |
| V419 Lot B | Geometric Mean Titer for Antibodies to Poliovirus Type 2 | 1276.56 Titer |
| V419 Lot C | Geometric Mean Titer for Antibodies to Poliovirus Type 2 | 1359.78 Titer |
| Control | Geometric Mean Titer for Antibodies to Poliovirus Type 2 | 846.14 Titer |
95% CI: [0.84, 1.05]
95% CI: [0.82, 1.02]
95% CI: [0.87, 1.09]
Primary
Geometric Mean Titer for Antibodies to Poliovirus Type 3
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.
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 Lot A | Geometric Mean Titer for Antibodies to Poliovirus Type 3 | 901.70 Titer |
| V419 Lot B | Geometric Mean Titer for Antibodies to Poliovirus Type 3 | 851.34 Titer |
| V419 Lot C | Geometric Mean Titer for Antibodies to Poliovirus Type 3 | 825.31 Titer |
| Control | Geometric Mean Titer for Antibodies to Poliovirus Type 3 | 784.24 Titer |
95% CI: [0.92, 1.22]
95% CI: [0.95, 1.26]
95% CI: [0.9, 1.19]
Secondary
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 106.30 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 121.00 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 101.81 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 104.70 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | 112.60 EU/mL |
p-value: <0.00195% CI: [0.79, 0.95]ANCOVA
Secondary
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 451.04 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 337.79 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 409.37 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 475.65 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | 471.52 EU/mL |
p-value: <0.00195% CI: [1.17, 1.46]ANCOVA
Secondary
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 104.51 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 142.32 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 94.26 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 108.69 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | 111.42 EU/mL |
p-value: 0.03595% CI: [0.66, 0.83]ANCOVA
Secondary
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 110.61 EU/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 102.82 EU/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 110.41 EU/mL |
| Control | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 110.62 EU/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pertussis Toxin | 110.79 EU/mL |
p-value: <0.00195% CI: [0.98, 1.17]Analysis of Covariance
Secondary
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes
Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 7F (n=1256, 191, 414, 419, 423) | 2.74 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 23F (n=1254, 190, 412, 419, 423) | 1.10 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19A (n=1254, 191, 413, 418, 423) | 1.60 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 9V (n=1256, 189, 414, 419, 423) | 1.35 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 5 (n=1256, 191, 414, 419, 423) | 1.49 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 1 (n=1256, 191, 414, 419, 423) | 1.44 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19F (n=1256, 191, 414, 419, 423) | 2.18 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 18C (n=1253, 191, 413, 418, 422) | 1.62 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6B (n=1255, 190, 414, 419, 422) | 1.01 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6A (n=1251, 191, 412, 417, 422) | 2.57 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 4 (n=1255, 189, 414, 418, 423) | 1.22 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 3 (n=1255, 191, 414, 418, 423) | 0.48 µg/mL |
| V419 Lot A | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 14 (n=1256, 191, 414, 419, 423) | 4.74 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 4 (n=1255, 189, 414, 418, 423) | 1.22 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6B (n=1255, 190, 414, 419, 422) | 1.29 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 23F (n=1254, 190, 412, 419, 423) | 1.20 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 7F (n=1256, 191, 414, 419, 423) | 3.08 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 3 (n=1255, 191, 414, 418, 423) | 0.50 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19A (n=1254, 191, 413, 418, 423) | 1.75 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 9V (n=1256, 189, 414, 419, 423) | 1.35 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 1 (n=1256, 191, 414, 419, 423) | 1.55 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 18C (n=1253, 191, 413, 418, 422) | 1.82 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 5 (n=1256, 191, 414, 419, 423) | 1.61 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19F (n=1256, 191, 414, 419, 423) | 2.26 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 14 (n=1256, 191, 414, 419, 423) | 4.83 µg/mL |
| V419 Lot B | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6A (n=1251, 191, 412, 417, 422) | 2.96 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6A (n=1251, 191, 412, 417, 422) | 2.49 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19F (n=1256, 191, 414, 419, 423) | 2.24 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 1 (n=1256, 191, 414, 419, 423) | 1.47 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 3 (n=1255, 191, 414, 418, 423) | 0.48 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 4 (n=1255, 189, 414, 418, 423) | 1.27 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 5 (n=1256, 191, 414, 419, 423) | 1.49 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6B (n=1255, 190, 414, 419, 422) | 1.01 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 7F (n=1256, 191, 414, 419, 423) | 2.78 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 9V (n=1256, 189, 414, 419, 423) | 1.40 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 14 (n=1256, 191, 414, 419, 423) | 4.91 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 18C (n=1253, 191, 413, 418, 422) | 1.69 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19A (n=1254, 191, 413, 418, 423) | 1.67 µg/mL |
| V419 Lot C | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 23F (n=1254, 190, 412, 419, 423) | 1.16 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 4 (n=1255, 189, 414, 418, 423) | 1.16 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6A (n=1251, 191, 412, 417, 422) | 2.66 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 23F (n=1254, 190, 412, 419, 423) | 1.07 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19A (n=1254, 191, 413, 418, 423) | 1.52 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 5 (n=1256, 191, 414, 419, 423) | 1.49 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 3 (n=1255, 191, 414, 418, 423) | 0.48 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19F (n=1256, 191, 414, 419, 423) | 2.11 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 9V (n=1256, 189, 414, 419, 423) | 1.30 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 1 (n=1256, 191, 414, 419, 423) | 1.40 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 7F (n=1256, 191, 414, 419, 423) | 2.75 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 18C (n=1253, 191, 413, 418, 422) | 1.62 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6B (n=1255, 190, 414, 419, 422) | 1.01 µg/mL |
| Control | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 14 (n=1256, 191, 414, 419, 423) | 4.85 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6A (n=1251, 191, 412, 417, 422) | 2.55 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 9V (n=1256, 189, 414, 419, 423) | 1.35 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 5 (n=1256, 191, 414, 419, 423) | 1.49 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 14 (n=1256, 191, 414, 419, 423) | 4.47 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 4 (n=1255, 189, 414, 418, 423) | 1.24 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 23F (n=1254, 190, 412, 419, 423) | 1.07 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 18C (n=1253, 191, 413, 418, 422) | 1.55 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 3 (n=1255, 191, 414, 418, 423) | 0.47 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19A (n=1254, 191, 413, 418, 423) | 1.61 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 6B (n=1255, 190, 414, 419, 422) | 1.01 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 19F (n=1256, 191, 414, 419, 423) | 2.19 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 7F (n=1256, 191, 414, 419, 423) | 2.70 µg/mL |
| V419 Lots A, B, and C Combined | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes | Serotype 1 (n=1256, 191, 414, 419, 423) | 1.44 µg/mL |
Comparison: Pneumococcal Serotype 1p-value: <0.00195% CI: [0.82, 1.04]ANCOVA
Comparison: Pneumococcal Serotype 3p-value: <0.00195% CI: [0.84, 1.06]ANCOVA
Comparison: Pneumococcal Serotype 4p-value: <0.00195% CI: [0.89, 1.12]ANCOVA
Comparison: Pneumococcal Serotype 5p-value: <0.00195% CI: [0.8, 1.07]ANCOVA
Comparison: Pneumococcal Serotype 6Ap-value: <0.00195% CI: [0.77, 0.99]ANCOVA
Comparison: Pneumococcal Serotype 6Bp-value: 0.05595% CI: [0.64, 0.96]ANCOVA
Comparison: Pneumococcal Serotype 7Fp-value: <0.00195% CI: [0.8, 0.99]ANCOVA
Comparison: Pneumococcal Serotype 9Vp-value: <0.00195% CI: [0.88, 1.13]ANCOVA
Comparison: Pneumococcal Serotype 14p-value: <0.00195% CI: [0.82, 1.1]ANCOVA
Comparison: Pneumococcal Serotype 18Cp-value: <0.00195% CI: [0.79, 1]ANCOVA
Comparison: Pneumococcal Serotype 19Ap-value: <0.00195% CI: [0.8, 1.03]ANCOVA
Comparison: Pneumococcal Serotype 19Fp-value: <0.00195% CI: [0.87, 1.08]ANCOVA
Comparison: Pneumococcal Serotype 23Fp-value: <0.00195% CI: [0.77, 1.06]ANCOVA
Secondary
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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: Fever (Pyrexia), \>=39.5°C rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, 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. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any decreased appetite | 47.4 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site pain | 5.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site erythema | 0.8 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any irritability | 79.8 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site swelling | 34.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe irritability | 6.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe decreased appetite | 1.3 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any pyrexia | 33.2 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe pyrexia | 1.3 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site swelling | 0.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any somnolence | 73.3 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site pain | 72.0 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe somnolence | 3.0 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any crying abnormal | 72.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any vomiting | 24.9 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe crying abnormal | 12.6 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe vomiting | 1.5 Percentage of participants |
| V419 Lot A | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site erythema | 40.8 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe vomiting | 0.8 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any crying abnormal | 74.8 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any pyrexia | 47.1 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site erythema | 0.3 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site pain | 70.0 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site pain | 6.0 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site swelling | 34.5 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe injection-site swelling | 0.5 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe crying abnormal | 9.5 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any decreased appetite | 48.5 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe decreased appetite | 1.4 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any irritability | 80.7 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe irritability | 7.8 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe pyrexia | 1.4 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any somnolence | 73.2 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Severe somnolence | 3.5 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any vomiting | 26.7 Percentage of participants |
| V419 Lot B | Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions | Any injection-site erythema | 44.6 Percentage of participants |
Secondary
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 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 Lot A | Percentage of Participants Responding to Diphtheria Toxin | 85.05 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Diphtheria Toxin | 84.80 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Diphtheria Toxin | 86.41 Percentage of participants |
| Control | Percentage of Participants Responding to Diphtheria Toxin | 87.71 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Diphtheria Toxin | 85.42 Percentage of participants |
95% CI: [-3.74, 4.24]
95% CI: [-5.26, 2.57]
95% CI: [-5.56, 2.28]
p-value: <0.00195% CI: [-6.02, 2.09]Miettinen and Nurminen
Secondary
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 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 Lot A | Percentage of Participants Responding to Hepatitis B Surface Antigen | 99.66 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Hepatitis B Surface Antigen | 100.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Hepatitis B Surface Antigen | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Hepatitis B Surface Antigen | 98.95 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Hepatitis B Surface Antigen | 99.89 Percentage of participants |
95% CI: [-1.23, 0.3]
95% CI: [-1.23, 0.32]
95% CI: [-0.64, 0.66]
p-value: <0.00195% CI: [0.2, 2.9]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 85.97 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 87.32 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 89.02 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 92.11 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 87.42 Percentage of participants |
95% CI: [-5.17, 2.47]
95% CI: [-6.79, 0.67]
95% CI: [-5.37, 1.94]
p-value: <0.00195% CI: [-7.73, -0.86]Miettinen and Nurminen
Secondary
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 95.33 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 95.40 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 96.06 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 94.36 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | 95.54 Percentage of participants |
p-value: <0.00195% CI: [-2.41, 3.22]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Pertussis Fimbriae | 86.95 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Fimbriae | 91.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Fimbriae | 91.08 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Fimbriae | 86.91 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Fimbriae | 89.66 Percentage of participants |
95% CI: [-7.69, -0.63]
95% CI: [-7.75, -0.66]
95% CI: [-3.32, 3.2]
p-value: <0.00195% CI: [-0.85, 7.36]Miettinen and Nurminen
Secondary
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Percentage of Participants Responding to Pertussis Fimbriae | 92.97 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Fimbriae | 90.15 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Fimbriae | 91.91 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Fimbriae | 94.17 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Fimbriae | 92.84 Percentage of participants |
p-value: <0.00195% CI: [-0.39, 7.4]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Pertussis Pertactin | 81.19 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Pertactin | 78.40 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Pertactin | 78.75 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Pertactin | 76.22 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Pertactin | 79.47 Percentage of participants |
95% CI: [-1.83, 7.39]
95% CI: [-2.21, 7.06]
95% CI: [-5.14, 4.42]
p-value: <0.00195% CI: [-1.7, 8.85]Miettinen and Nurminen
Secondary
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Percentage of Participants Responding to Pertussis Pertactin | 92.16 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Pertactin | 91.09 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Pertactin | 91.28 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Pertactin | 92.08 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Pertactin | 93.14 Percentage of participants |
p-value: <0.00195% CI: [-2.13, 5.47]Miettinen and Nurminen
Secondary
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 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 Lot A | Percentage of Participants Responding to Pertussis Toxin | 99.33 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Toxin | 97.61 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Toxin | 98.97 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Toxin | 97.92 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Toxin | 98.64 Percentage of participants |
95% CI: [0.37, 3.4]
95% CI: [-0.77, 1.63]
95% CI: [-3.03, 0.15]
p-value: <0.00195% CI: [-0.59, 3.14]Miettinen and Nurminen
Secondary
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 \<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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 Lot A | Percentage of Participants Responding to Pertussis Toxin | 98.51 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Pertussis Toxin | 98.43 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Pertussis Toxin | 99.25 Percentage of participants |
| Control | Percentage of Participants Responding to Pertussis Toxin | 98.12 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Pertussis Toxin | 98.18 Percentage of participants |
p-value: <0.00195% CI: [-1.11, 2.58]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Poliovirus Type 1 | 100.00 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Poliovirus Type 1 | 100.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Poliovirus Type 1 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 1 | 99.35 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Poliovirus Type 1 | 100.00 Percentage of participants |
95% CI: [-0.61, 0.61]
95% CI: [-0.61, 0.61]
95% CI: [-0.61, 0.61]
p-value: <0.00195% CI: [0.18, 2.36]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Poliovirus Type 2 | 100.00 Percentage of participants |
95% CI: [-0.61, 0.61]
95% CI: [-0.61, 0.6]
95% CI: [-0.61, 0.6]
p-value: <0.00195% CI: [-0.2, 1.24]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Poliovirus Type 3 | 100.00 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Poliovirus Type 3 | 100.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Poliovirus Type 3 | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Poliovirus Type 3 | 99.67 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Poliovirus Type 3 | 100.00 Percentage of participants |
95% CI: [-0.61, 0.61]
95% CI: [-0.61, 0.61]
95% CI: [-0.61, 0.61]
p-value: <0.00195% CI: [0.05, 1.85]Miettinen and Nurminen
Secondary
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 a 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 Lot A | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1 µg/mL | 86.75 Percentage of participants |
| V419 Lot A | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 µg/mL | 99.01 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1 µg/mL | 87.25 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 µg/mL | 98.32 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1 µg/mL | 88.40 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 µg/mL | 97.82 Percentage of participants |
| Control | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 µg/mL | 96.18 Percentage of participants |
| Control | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1 µg/mL | 79.51 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=1 µg/mL | 87.47 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Titer >=0.15 µg/mL | 98.38 Percentage of participants |
Comparison: Equivalence for titer \>=1 µg/mL95% CI: [-4.31, 3.35]
Comparison: Equivalence for titer \>=1 µg/mL95% CI: [-5.38, 2.12]
Comparison: Equivalence for titer \>=1 µg/mL95% CI: [-4.89, 2.58]
Comparison: Non-inferiority for titer \>=1 µg/mLp-value: <0.00195% CI: [3.38, 13.17]Miettinen and Nurminen
Comparison: Non-inferiority for titer \>=0.15 µg/mLp-value: <0.00195% CI: [0.39, 5.12]Miettinen and Nurminen
Secondary
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 Lot A | Percentage of Participants Responding to Tetanus Toxin | 99.84 Percentage of participants |
| V419 Lot B | Percentage of Participants Responding to Tetanus Toxin | 100.00 Percentage of participants |
| V419 Lot C | Percentage of Participants Responding to Tetanus Toxin | 100.00 Percentage of participants |
| Control | Percentage of Participants Responding to Tetanus Toxin | 98.67 Percentage of participants |
| V419 Lots A, B, and C Combined | Percentage of Participants Responding to Tetanus Toxin | 99.95 Percentage of participants |
95% CI: [-0.91, 0.47]
95% CI: [-0.9, 0.47]
95% CI: [-0.63, 0.62]
p-value: <0.00195% CI: [0.46, 3.33]Miettinen and Nurminen
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 defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | All routes <38.0°C | 50.8 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.0°C and <38.5°C, mild | 27.2 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.5°C and <39.5°C, moderate | 19.5 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | All routes >=39.5°C, severe | 2.4 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | Rectal <38.0°C | 47.7 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.0°C and <38.5°C, mild | 26.5 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.5°C and <39.5°C, moderate | 19.0 Percentage of participants |
| V419 Lot A | Percentage of Participants With Elevated Temperature by Severity | Rectal >=39.5°C, severe | 2.4 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | Rectal >=39.5°C, severe | 1.3 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | All routes <38.0°C | 64.6 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | Rectal <38.0°C | 59.0 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.0°C and <38.5°C, mild | 23.3 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.5°C and <39.5°C, moderate | 10.6 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | All routes >=38.5°C and <39.5°C, moderate | 10.8 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | Rectal >=38.0°C and <38.5°C, mild | 23.0 Percentage of participants |
| V419 Lot B | Percentage of Participants With Elevated Temperature by Severity | All routes >=39.5°C, severe | 1.3 Percentage of participants |
Comparison: Estimated Difference, all routes \<38.0°C95% CI: [-18.8, -8.4]
Comparison: Estimated Difference, all routes \>=38°C and \<38.5°95% CI: [-0.9, 8.3]
Comparison: Estimated Difference, all routes \>=38.5°C and \<39.5°95% CI: [4.8, 11.9]
Comparison: Estimated Difference, all routes \>=39.5°C95% CI: [-0.7, 2.2]
Comparison: Estimated Difference; rectal \<38.0°C95% CI: [-16.6, -5.9]
Comparison: Estimated Difference; rectal \>=38.0°C and \<38.5°C95% CI: [-1.4, 7.8]
Comparison: Estimated Difference, rectal \>=38.5°C and \<39.5°C95% CI: [4.6, 11.6]
Comparison: Estimated Difference, rectal \>=39.5°C95% CI: [-0.7, 2.1]