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| Name | Class |
|---|---|
| MCM Vaccines B.V. | INDUSTRY |
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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™.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V419 Lot A | Experimental | V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
|
| V419 Lot B | Experimental | V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
|
| V419 Lot C | Experimental | V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
|
| Control | Active Comparator | Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V419 | Biological | V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postdose 3 (Month 7) |
| 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). | Postdose 3 (Month 7) |
| 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). | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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). | Postdose 3 (Month 7) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postdose 3 (Month 7) |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27846058 | Result | Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Infant Series |
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| ||||||||||||||||||
| Period 2: Interim Period |
| |||||||||||||||||||
| Period 3: Toddler Vaccinations |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | V419 Lot B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Postdose 3 (Month 7) |
|
SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination
The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V419 Lots A, B, and C Combined | V419 (Lot A, B, or 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| C512971 | pentacel |
| C538862 | 13-valent pneumococcal vaccine |
| C492535 | RotaTeq |
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|
| PENTACEL™ | Biological | PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group |
|
| Prevnar 13™ | Biological | Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age |
|
| RotaTeq™ | Biological | RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age |
|
| Recombivax HB vaccine | Biological | Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age |
|
| Postdose 3 (Month 7) |
| Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. | Postdose 3 (Month 7) |
| Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. | Postdose 3 (Month 7) |
| 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). | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 3 (Month 7) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 4 (Month 16) |
| 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. | Postdose 3 (Month 7) |
| 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. | Up to 5 days after any infant vaccination (up to 6 months) |
| 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. | Up to 5 days after any infant vaccination (up to 6 months) |
| Adverse Event |
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| Death |
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| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Randomized but not vaccinated |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | V419 Lots A, B, and C Combined | V419 (Lot A, B, or 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. |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Postdose 3 (Month 7) |
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|
| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Postdose 3 (Month 7) |
|
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|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Postdose 3 (Month 7) |
|
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 3 (Month 7) |
|
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|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 3 (Month 7) |
|
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| Primary | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 3 (Month 7) |
|
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| Primary | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 3 (Month 7) |
|
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Postdose 3 (Month 7) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Postdose 3 (Month 7) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Postdose 3 (Month 7) |
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|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postdose 4 (Month 16) |
|
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Postdose 3 (Month 7) |
|
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Up to 5 days after any infant vaccination (up to 6 months) |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Up to 5 days after any infant vaccination (up to 6 months) |
|
|
|
|
| 94 |
| 2,390 |
| 2,259 |
| 2,390 |
| EG001 | 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. | 15 | 397 | 371 | 397 |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| intussusception | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden infant death syndrome | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Chest wall abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Coxsackie viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Eczema herpeticum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gatroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Vulval abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Crying | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection-site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection-site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection-site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D016908 | Gram-Positive Bacterial Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
| Titer >=0.15 µg/mL |
|
|
Equivalence for titer >=1 µg/mL |
| Response Rate Difference (Lot A - Lot C) |
| -1.62 |
| 2-Sided |
| 95 |
| -5.38 |
| 2.12 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Equivalence for titer >=1 µg/mL | Response Rate Difference (Lot B - Lot C) | -1.16 | 2-Sided | 95 | -4.89 | 2.58 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Non-inferiority for titer >=1 µg/mL | Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 7.93 | 2-Sided | 95 | 3.38 | 13.17 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Non-inferiority for titer >=0.15 µg/mL | Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 2.20 | 2-Sided | 95 | 0.39 | 5.12 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5% |
| GMC Ratio (Lot A/Lot C) |
| 0.85 |
| 2-Sided |
| 95 |
| 0.74 |
| 0.96 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 0.98 | 2-Sided | 95 | 0.86 | 1.11 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot A/Lot C) |
| 0.97 |
| 2-Sided |
| 95 |
| 0.86 |
| 1.09 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 1.02 | 2-Sided | 95 | 0.90 | 1.14 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot A/Lot C) |
| 1.02 |
| 2-Sided |
| 95 |
| 0.95 |
| 1.09 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 1.05 | 2-Sided | 95 | 0.98 | 1.13 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot A/Lot C) |
| 1.02 |
| 2-Sided |
| 95 |
| 0.95 |
| 1.09 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 0.99 | 2-Sided | 95 | 0.92 | 1.06 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| Secondary analysis | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 1.20 | 2-Sided | 95 | 1.11 | 1.29 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| GMC Ratio (Lot A/Lot C) |
| 0.78 |
| 2-Sided |
| 95 |
| 0.72 |
| 0.83 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 0.87 | 2-Sided | 95 | 0.81 | 0.94 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| Secondary analysis | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | 0.419 | GMC Ratio (Combined/Control) | 0.67 | 2-Sided | 95 | 0.62 | 0.73 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| GMC Ratio (Lot A/Lot C) |
| 0.93 |
| 2-Sided |
| 95 |
| 0.83 |
| 1.05 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 0.96 | 2-Sided | 95 | 0.85 | 1.08 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| Secondary analysis | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 1.03 | 2-Sided | 95 | 0.90 | 1.17 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| GMC Ratio (Lot A/Lot C) |
| 0.80 |
| 2-Sided |
| 95 |
| 0.73 |
| 0.87 |
GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| GMC Ratio (Lot B/Lot C) | 1.02 | 2-Sided | 95 | 0.93 | 1.11 | GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5 |
| Secondary analysis | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 1.51 | 2-Sided | 95 | 1.37 | 1.66 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| GMT Ratio (Lot A/Lot C) |
| 0.88 |
| 2-Sided |
| 95 |
| 0.79 |
| 0.99 |
GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| GMT Ratio (Lot B/Lot C) | 1.03 | 2-Sided | 95 | 0.92 | 1.15 | GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| GMT Ratio (Lot A/Lot C) |
| 0.91 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.02 |
GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| GMT Ratio (Lot B/Lot C) | 0.98 | 2-Sided | 95 | 0.87 | 1.09 | GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| GMT Ratio (Lot A/Lot C) |
| 1.09 |
| 2-Sided |
| 95 |
| 0.95 |
| 1.26 |
GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| GMT Ratio (Lot B/Lot C) | 1.03 | 2-Sided | 95 | 0.90 | 1.19 | GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5 |
| Response Rate Difference (Lot A - Lot C) |
| -0.34 |
| 2-Sided |
| 95 |
| -1.23 |
| 0.32 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | 0.00 | 2-Sided | 95 | -0.64 | 0.66 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 0.92 | 2-Sided | 95 | 0.20 | 2.90 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| -1.35 |
| 2-Sided |
| 95 |
| -5.26 |
| 2.57 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | -1.64 | 2-Sided | 95 | -5.56 | 2.28 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | -2.35 | 2-Sided | 95 | -6.02 | 2.09 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| -0.16 |
| 2-Sided |
| 95 |
| -0.90 |
| 0.47 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Response Rate Difference (Lot B - Lot C) | 0.00 | 2-Sided | 95 | -0.63 | 0.62 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 1.28 | 2-Sided | 95 | 0.46 | 3.33 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5% |
| Response Rate Difference (Lot A - Lot C) |
| 0.36 |
| 2-Sided |
| 95 |
| -0.77 |
| 1.63 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | -1.36 | 2-Sided | 95 | -3.03 | 0.15 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 0.72 | 2-Sided | 95 | -0.59 | 3.14 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| -3.06 |
| 2-Sided |
| 95 |
| -6.79 |
| 0.67 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | -1.71 | 2-Sided | 95 | -5.37 | 1.94 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | -4.70 | 2-Sided | 95 | -7.73 | -0.86 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| 2.41 |
| 2-Sided |
| 95 |
| -2.21 |
| 7.06 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | -0.36 | 2-Sided | 95 | -5.14 | 4.42 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 3.28 | 2-Sided | 95 | -1.70 | 8.85 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| -4.17 |
| 2-Sided |
| 95 |
| -7.75 |
| -0.66 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Response Rate Difference (Lot B - Lot C) | -0.07 | 2-Sided | 95 | -3.32 | 3.20 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 2.85 | 2-Sided | 95 | -0.85 | 7.36 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10% |
| Response Rate Difference (Lot A - Lot C) |
| 0.00 |
| 2-Sided |
| 95 |
| -0.61 |
| 0.61 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Response Rate Difference (Lot B - Lot C) | 0.00 | 2-Sided | 95 | -0.61 | 0.61 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 0.66 | 2-Sided | 95 | 0.18 | 2.36 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5% |
| Response Rate Difference (Lot A - Lot C) |
| 0.00 |
| 2-Sided |
| 95 |
| -0.61 |
| 0.60 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Response Rate Difference (Lot B - Lot C) | 0.00 | 2-Sided | 95 | -0.61 | 0.60 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 0.00 | 2-Sided | 95 | -0.20 | 1.24 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5% |
| Response Rate Difference (Lot A - Lot C) |
| 0.00 |
| 2-Sided |
| 95 |
| -0.61 |
| 0.61 |
Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine |
| Non-Inferiority or Equivalence |
Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Response Rate Difference (Lot B - Lot C) | 0.00 | 2-Sided | 95 | -0.61 | 0.61 | Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine | Non-Inferiority or Equivalence | Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5% |
| Miettinen and Nurminen | Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine | <0.001 | Response Rate Difference (Comb - Ctrl) | 0.33 | 2-Sided | 95 | 0.05 | 1.85 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5% |
| Serotype 3 (n=1255, 191, 414, 418, 423) |
|
| Serotype 4 (n=1255, 189, 414, 418, 423) |
|
| Serotype 5 (n=1256, 191, 414, 419, 423) |
|
| Serotype 6A (n=1251, 191, 412, 417, 422) |
|
| Serotype 6B (n=1255, 190, 414, 419, 422) |
|
| Serotype 7F (n=1256, 191, 414, 419, 423) |
|
| Serotype 9V (n=1256, 189, 414, 419, 423) |
|
| Serotype 14 (n=1256, 191, 414, 419, 423) |
|
| Serotype 18C (n=1253, 191, 413, 418, 422) |
|
| Serotype 19A (n=1254, 191, 413, 418, 423) |
|
| Serotype 19F (n=1256, 191, 414, 419, 423) |
|
| Serotype 23F (n=1254, 190, 412, 419, 423) |
|
| Pneumococcal Serotype 3 | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.95 | 2-Sided | 95 | 0.84 | 1.06 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 4 | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 1.00 | 2-Sided | 95 | 0.89 | 1.12 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 5 | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.93 | 2-Sided | 95 | 0.80 | 1.07 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 6A | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.87 | 2-Sided | 95 | 0.77 | 0.99 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 6B | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | 0.055 | GMC Ratio (Combined/Control) | 0.79 | 2-Sided | 95 | 0.64 | 0.96 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 7F | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.89 | 2-Sided | 95 | 0.80 | 0.99 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 9V | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 1.00 | 2-Sided | 95 | 0.88 | 1.13 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 14 | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.95 | 2-Sided | 95 | 0.82 | 1.10 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 18C | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.89 | 2-Sided | 95 | 0.79 | 1.00 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 19A | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.91 | 2-Sided | 95 | 0.80 | 1.03 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 19F | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.97 | 2-Sided | 95 | 0.87 | 1.08 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Pneumococcal Serotype 23F | ANCOVA | GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine | <0.001 | GMC Ratio (Combined/Control) | 0.90 | 2-Sided | 95 | 0.77 | 1.06 | Non-Inferiority or Equivalence | Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67 |
| Any injection-site pain |
|
| Severe injection-site pain |
|
| Any injection-site swelling |
|
| Severe injection-site swelling |
|
| Any crying abnormal |
|
| Severe crying abnormal |
|
| Any decreased appetite |
|
| Severe decreased appetite |
|
| Any irritability |
|
| Severe irritability |
|
| Any pyrexia |
|
| Severe pyrexia |
|
| Any somnolence |
|
| Severe somnolence |
|
| Any vomiting |
|
| Severe vomiting |
|
| All routes >=38.5°C and <39.5°C, moderate |
|
| All routes >=39.5°C, severe |
|
| Rectal <38.0°C |
|
| Rectal >=38.0°C and <38.5°C, mild |
|
| Rectal >=38.5°C and <39.5°C, moderate |
|
| Rectal >=39.5°C, severe |
|
Estimated Difference, all routes >=38°C and <38.5° |
| Mean Difference (Final Values) |
| 3.9 |
| 2-Sided |
| 95 |
| -0.9 |
| 8.3 |
Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. |
| Superiority or Other |
| Estimated Difference, all routes >=38.5°C and <39.5° | Mean Difference (Final Values) | 8.7 | 2-Sided | 95 | 4.8 | 11.9 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |
| Estimated Difference, all routes >=39.5°C | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -0.7 | 2.2 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |
| Estimated Difference; rectal <38.0°C | Mean Difference (Final Values) | -11.3 | 2-Sided | 95 | -16.6 | -5.9 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |
| Estimated Difference; rectal >=38.0°C and <38.5°C | Mean Difference (Final Values) | 3.5 | 2-Sided | 95 | -1.4 | 7.8 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |
| Estimated Difference, rectal >=38.5°C and <39.5°C | Mean Difference (Final Values) | 8.4 | 2-Sided | 95 | 4.6 | 11.6 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |
| Estimated Difference, rectal >=39.5°C | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -0.7 | 2.1 | Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method. | Superiority or Other |