Healthy Children After Vaccination
Conditions
Keywords
vaccine, infant, healthy subjects
Brief summary
This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care. The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to \< 39 degrees C; \> 39 to \< 40 degrees C and \> 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
Interventions
Non-interventional observational study
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation: * Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media). * Parents or legal guardians willing and able to complete the diary cards.
Exclusion criteria
* Hypersensitivity to the active substances or to any of the excipients; * Hypersensitivity to diphtheria toxoid; * Age less than 3 months or greater than or equal to 2 years at enrollment; * Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines; * Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine; * Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Febrile Reactions Post-dose 1 | Day 1 to Day 3 post-dose 1 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (\>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of \>=38 degrees C to less than or equal to (\<=) 39 degrees C, \>39 degrees C to \<=40 degrees C and \>40 degrees C were observed. |
| Percentage of Participants With Febrile Reactions Post-dose 2 | Day 1 to Day 3 post-dose 2 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed. |
| Percentage of Participants With Febrile Reactions Post-dose 3 | Day 1 to Day 3 post-dose 3 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed. |
| Percentage of Participants With Febrile Reactions Post-dose 4 | Day 1 to Day 3 post-dose 4 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C was observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Day 1 to Day 3 post-dose 1 | Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Day 1 to Day 3 post-dose 2 | Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Day 1 to Day 3 post-dose 1 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 centimeters \[cm\]); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Day 1 to Day 3 post-dose 4 | Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Day 1 to Day 3 post-dose 3 | Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Day 1 to Day 3 post-dose 2 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Day 1 to Day 3 post-dose 3 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Day 1 to Day 3 post-dose 4 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Cohort (3-6 Months) Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC. | 14 |
| Catch-up Cohort (7-11 Months) Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC. | 31 |
| Catch-up Cohort (12-23 Months) Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC. | 55 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Participant failed to return | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Total | Catch-up Cohort (12-23 Months) | Catch-up Cohort (7-11 Months) | Primary Cohort (3-6 Months) |
|---|---|---|---|---|
| Age, Customized 12 to 23 months | 55 Participants | 55 Participants | 0 Participants | 0 Participants |
| Age, Customized 3 to 6 months | 14 Participants | 0 Participants | 0 Participants | 14 Participants |
| Age, Customized 7 to 11 months | 31 Participants | 0 Participants | 31 Participants | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 19 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 63 Participants | 36 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 14 | 6 / 13 | 6 / 13 | 2 / 7 | 17 / 31 | 8 / 29 | 5 / 26 | 27 / 55 | 16 / 54 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 7 | 1 / 31 | 0 / 29 | 0 / 26 | 1 / 55 | 0 / 54 |
Outcome results
Primary
Percentage of Participants With Febrile Reactions Post-dose 1
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (\>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of \>=38 degrees C to less than or equal to (\<=) 39 degrees C, \>39 degrees C to \<=40 degrees C and \>40 degrees C were observed.
Time frame: Day 1 to Day 3 post-dose 1
Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | 38 to 39 degrees C | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | >39 to 40 degrees C | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | 38 to 39 degrees C | 16.1 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | >39 to 40 degrees C | 3.2 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | 38 to 39 degrees C | 1.8 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Febrile Reactions Post-dose 1 | >39 to 40 degrees C | 3.6 Percentage of participants |
Primary
Percentage of Participants With Febrile Reactions Post-dose 2
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed.
Time frame: Day 1 to Day 3 post-dose 2
Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Febrile Reactions Post-dose 2 | 23.1 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Febrile Reactions Post-dose 2 | 10.3 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Febrile Reactions Post-dose 2 | 0.0 Percentage of participants |
Primary
Percentage of Participants With Febrile Reactions Post-dose 3
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C to \<=39 degrees C was observed.
Time frame: Day 1 to Day 3 post-dose 3
Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Febrile Reactions Post-dose 3 | 15.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Febrile Reactions Post-dose 3 | 0.0 Percentage of participants |
Primary
Percentage of Participants With Febrile Reactions Post-dose 4
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of \>=38 degrees C. Percentage of participants with febrile reaction of \>=38 degrees C was observed.
Time frame: Day 1 to Day 3 post-dose 4
Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Febrile Reactions Post-dose 4 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 centimeters \[cm\]); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Time frame: Day 1 to Day 3 post-dose 1
Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Swelling | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hemorrhage | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hematoma | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Redness | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site warmth | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site induration | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Tenderness | 7.1 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hematoma | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Redness | 19.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Swelling | 6.5 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Tenderness | 29.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hemorrhage | 3.2 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site induration | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site warmth | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hemorrhage | 1.8 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Swelling | 25.5 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site warmth | 1.8 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site induration | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Injection site hematoma | 1.8 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Tenderness | 23.6 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Redness | 27.3 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Time frame: Day 1 to Day 3 post-dose 2
Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site hemorrhage | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Tenderness | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Redness | 23.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Swelling | 0.0 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site induration | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Tenderness | 6.9 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Redness | 13.8 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Swelling | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site hemorrhage | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site induration | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site induration | 1.9 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Injection site hemorrhage | 3.7 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Redness | 20.4 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Tenderness | 16.7 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Swelling | 11.1 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Time frame: Day 1 to Day 3 post-dose 3
Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Redness | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Swelling | 7.7 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Tenderness | 7.7 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Injection site induration | 7.7 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Injection site induration | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Redness | 3.8 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Tenderness | 7.7 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Swelling | 3.8 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (\<2.5 cm); Moderate (\>=2.5 cm to \<5.0 cm); Severe (\>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Time frame: Day 1 to Day 3 post-dose 4
Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Redness | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Swelling | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Injection site induration | 14.3 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 to Day 3 post-dose 1
Population: Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Decreased appetite | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Diarrhea | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Fever | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Restless sleep | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual crying | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual fussiness | 7.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual irritability | 21.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Vomiting | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Fever | 19.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual irritability | 19.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Restless sleep | 32.3 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual crying | 25.8 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual fussiness | 6.5 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Decreased appetite | 19.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Diarrhea | 3.2 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Vomiting | 6.5 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Fever | 5.5 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Diarrhea | 9.1 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Decreased appetite | 23.6 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Restless sleep | 27.3 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual irritability | 25.5 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual fussiness | 12.7 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Unusual crying | 30.9 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Vomiting | 3.6 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 to Day 3 post-dose 2
Population: Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Decreased appetite | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Diarrhea | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Fever | 23.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Restless sleep | 23.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual crying | 23.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual fussiness | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual irritability | 23.1 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Vomiting | 7.7 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Fever | 10.3 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual irritability | 6.9 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Restless sleep | 24.1 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual crying | 20.7 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual fussiness | 6.9 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Decreased appetite | 10.3 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Diarrhea | 3.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Vomiting | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Fever | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Diarrhea | 0.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Decreased appetite | 9.3 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Restless sleep | 16.7 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual irritability | 9.3 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual fussiness | 7.4 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Unusual crying | 13.0 Percentage of participants |
| Catch-up Cohort (12-23 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Vomiting | 1.9 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 to Day 3 post-dose 3
Population: Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Decreased appetite | 7.7 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Diarrhea | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Fever | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Restless sleep | 46.2 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual crying | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual fussiness | 15.4 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual irritability | 7.7 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Vomiting | 15.4 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Vomiting | 3.8 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Decreased appetite | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual crying | 11.5 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Diarrhea | 3.8 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual irritability | 7.7 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Fever | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Unusual fussiness | 0.0 Percentage of participants |
| Catch-up Cohort (7-11 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Restless sleep | 11.5 Percentage of participants |
Secondary
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Systemic events (any fever \>=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 to Day 3 post-dose 4
Population: Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Restless sleep | 28.6 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Unusual crying | 14.3 Percentage of participants |
| Primary Cohort (3-6 Months) | Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Unusual irritability | 14.3 Percentage of participants |