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NCT00853749: REPLAY

Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

Completed Phase 3 Results posted Last updated 11 November 2021
What this trial tests

Phase 3 trial testing 13-valent pneumococcal conjugate vaccine (13vPnC) in Invasive Pneumococcal Disease in 89 participants. Completed in 16 December 2009.

Timeline
5 May 2009
Primary endpoint
16 December 2009
16 December 2009

Quick facts

Lead sponsorWyeth is now a wholly owned subsidiary of Pfizer
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Maskingnone
Primary purposeother
Enrollment89
Start date5 May 2009
Primary completion16 December 2009
Estimated completion16 December 2009
Sites2 locations across Iceland

Drugs / interventions tested

Conditions studied

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 5 to 7, any sex, with Invasive Pneumococcal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination Primary · Day 28

Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Common Serotype 4
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC97.385.8 – 99.9
Common Serotype 6B
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC100.090.5 – 100.0
Common Serotype 9V
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC100.090.5 – 100.0
Common Serotype 14
GroupValue95% CI
PCV/23vPS/13vPnC100.092.7 – 100.0
PCV/PCV/13vPnC100.090.5 – 100.0
Common Serotype18C
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC97.385.8 – 99.9
Common Serotype 19F
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC100.090.5 – 100.0
Common Serotype 23F
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC100.090.5 – 100.0
Additional Serotype 1
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC97.385.8 – 99.9
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination Primary · Day 28

Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Common Serotype 4
GroupValue95% CI
PCV/23vPS/13vPnC98.089.4 – 99.9
PCV/PCV/13vPnC97.285.5 – 99.9
Common Serotype 6B
GroupValue95% CI
PCV/23vPS/13vPnC100.092.7 – 100.0
PCV/PCV/13vPnC100.090.3 – 100.0
Common Serotype 9V
GroupValue95% CI
PCV/23vPS/13vPnC100.092.7 – 100.0
PCV/PCV/13vPnC100.090.3 – 100.0
Common Serotype 14
GroupValue95% CI
PCV/23vPS/13vPnC100.092.7 – 100.0
PCV/PCV/13vPnC100.090.3 – 100.0
Common Serotype 18C
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC100.090.0 – 100.0
Common Serotype 19F
GroupValue95% CI
PCV/23vPS/13vPnC100.092.7 – 100.0
PCV/PCV/13vPnC100.090.0 – 100.0
Common Serotype 23F
GroupValue95% CI
PCV/23vPS/13vPnC98.089.4 – 99.9
PCV/PCV/13vPnC100.089.7 – 100.0
Additional Serotype 1
GroupValue95% CI
PCV/23vPS/13vPnC100.092.9 – 100.0
PCV/PCV/13vPnC97.385.8 – 99.9
Antibody Response Measured 1 Month After Vaccination (Avidity Assay) Secondary · Day 28

Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).

Additional serotype 1
GroupValue95% CI
PCV/23vPS/13vPnC1.421.15 – 1.76
PCV/PCV/13vPnC4.683.62 – 6.04
Additional serotype 5
GroupValue95% CI
PCV/23vPS/13vPnC1.851.46 – 2.36
PCV/PCV/13vPnC5.854.81 – 7.11
Common serotype 6B
GroupValue95% CI
PCV/23vPS/13vPnC2.431.77 – 3.35
PCV/PCV/13vPnC5.484.38 – 6.86
Common serotype 19F
GroupValue95% CI
PCV/23vPS/13vPnC2.171.69 – 2.79
PCV/PCV/13vPnC2.461.88 – 3.21
Common serotype 23F
GroupValue95% CI
PCV/23vPS/13vPnC3.022.36 – 3.85
PCV/PCV/13vPnC6.435.33 – 7.76
Antibody Response Measured 1 Month After Vaccination (OPA) Secondary · Day 28

Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Common Serotype 4
GroupValue95% CI
PCV/23vPS/13vPnC23741656.3 – 3404.0
PCV/PCV/13vPnC37652339.1 – 6059.8
Common Serotype 6B
GroupValue95% CI
PCV/23vPS/13vPnC111569073.5 – 13715.2
PCV/PCV/13vPnC114778418.5 – 15646.8
Common Serotype 9V
GroupValue95% CI
PCV/23vPS/13vPnC16511067.8 – 2553.3
PCV/PCV/13vPnC17131087.0 – 2700.0
Common Serotype 14
GroupValue95% CI
PCV/23vPS/13vPnC30412311.4 – 4001.1
PCV/PCV/13vPnC30482318.3 – 4006.9
Common Serotype 18C
GroupValue95% CI
PCV/23vPS/13vPnC32302616.1 – 3987.1
PCV/PCV/13vPnC56843122.2 – 10349.6
Common Serotype 19F
GroupValue95% CI
PCV/23vPS/13vPnC12661013.9 – 1582.0
PCV/PCV/13vPnC1198842.3 – 1703.9
Common Serotype 23F
GroupValue95% CI
PCV/23vPS/13vPnC16781212.3 – 2322.1
PCV/PCV/13vPnC27141970.1 – 3739.5
Additional Serotype 1
GroupValue95% CI
PCV/23vPS/13vPnC217162.6 – 290.5
PCV/PCV/13vPnC1087717.5 – 1646.3
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination Secondary · Day 28

Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.

Common serotype 4
GroupValue95% CI
PCV/23vPS/13vPnC4.183.38 – 5.16
PCV/PCV/13vPnC11.347.74 – 16.62
Common serotype 6B
GroupValue95% CI
PCV/23vPS/13vPnC29.5121.32 – 40.83
PCV/PCV/13vPnC41.7029.01 – 59.96
Common serotype 9V
GroupValue95% CI
PCV/23vPS/13vPnC4.313.68 – 5.04
PCV/PCV/13vPnC7.396.05 – 9.03
Common serotype 14
GroupValue95% CI
PCV/23vPS/13vPnC17.4712.76 – 23.93
PCV/PCV/13vPnC22.7815.75 – 32.96
Common serotype 18C
GroupValue95% CI
PCV/23vPS/13vPnC2.762.15 – 3.56
PCV/PCV/13vPnC4.833.48 – 6.71
Common serotype 19F
GroupValue95% CI
PCV/23vPS/13vPnC9.787.45 – 12.83
PCV/PCV/13vPnC11.608.46 – 15.92
Common serotype 23F
GroupValue95% CI
PCV/23vPS/13vPnC7.896.18 – 10.07
PCV/PCV/13vPnC12.258.92 – 16.81
Additional serotype 1
GroupValue95% CI
PCV/23vPS/13vPnC5.284.22 – 6.61
PCV/PCV/13vPnC19.4313.77 – 27.41
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination Secondary · Day 1 through Day 4

Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.

Tenderness: Any
GroupValue95% CI
PCV/23vPS/13vPnC88.0
PCV/PCV/13vPnC76.9
Tenderness: Significant
GroupValue95% CI
PCV/23vPS/13vPnC12.0
PCV/PCV/13vPnC20.5
Redness: Any
GroupValue95% CI
PCV/23vPS/13vPnC50.0
PCV/PCV/13vPnC66.7
Redness: Mild
GroupValue95% CI
PCV/23vPS/13vPnC10.0
PCV/PCV/13vPnC15.8
Redness: Moderate
GroupValue95% CI
PCV/23vPS/13vPnC40.0
PCV/PCV/13vPnC52.6
Redness: Severe
GroupValue95% CI
PCV/23vPS/13vPnC10.0
PCV/PCV/13vPnC21.1
Swelling: Any
GroupValue95% CI
PCV/23vPS/13vPnC44.0
PCV/PCV/13vPnC59.0
Swelling: Mild
GroupValue95% CI
PCV/23vPS/13vPnC16.3
PCV/PCV/13vPnC26.3
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination Secondary · Day 1 through Day 4

Pre-specified systemic events (any fever 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.

Fever ≥ 38 degrees C but ≤ 39 degrees C
GroupValue95% CI
PCV/23vPS/13vPnC2.0
PCV/PCV/13vPnC2.8
Decreased appetite
GroupValue95% CI
PCV/23vPS/13vPnC12.2
PCV/PCV/13vPnC10.3
Irritability
GroupValue95% CI
PCV/23vPS/13vPnC18.4
PCV/PCV/13vPnC11.4
Increased sleep
GroupValue95% CI
PCV/23vPS/13vPnC4.0
PCV/PCV/13vPnC12.8
Decreased sleep
GroupValue95% CI
PCV/PCV/13vPnC5.1
Rash
GroupValue95% CI
PCV/23vPS/13vPnC6.0
PCV/PCV/13vPnC2.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PCV/23vPS/13vPnC
Serious: 0/50 (0%)
Deaths: —
PCV/PCV/13vPnC
Serious: 0/39 (0%)
Deaths: —
Other adverse events (31 terms — click to expand)

ReactionSystemPCV/23vPS/13vPnCPCV/PCV/13vPnC
Tenderness (Any)Skin and subcutaneous tissue disorders——
Redness (Any)Skin and subcutaneous tissue disorders——
Swelling (Any)Skin and subcutaneous tissue disorders——
Redness (Moderate)Skin and subcutaneous tissue disorders——
Swelling (Moderate)Skin and subcutaneous tissue disorders——
Swelling (Mild)Skin and subcutaneous tissue disorders——
IrritabilityGeneral disorders——
Tenderness (Significant)Skin and subcutaneous tissue disorders——
Redness (Severe)Skin and subcutaneous tissue disorders——
Redness (Mild)Skin and subcutaneous tissue disorders——
Decreased appetiteGeneral disorders——
Increased sleepGeneral disorders——
Viral infectionInfections and infestations——
Swelling (Severe)Skin and subcutaneous tissue disorders——
RashGeneral disorders——
VomitingGastrointestinal disorders——
DiarrhoeaGastrointestinal disorders——
Decreased sleepGeneral disorders——
LymphadenopathyBlood and lymphatic system disorders——
Abdominal painGastrointestinal disorders——
Abdominal pain upperGastrointestinal disorders——
PyrexiaGeneral disorders——
InfluenzaInfections and infestations——
GastroenteritisInfections and infestations——
PharyngitisInfections and infestations——
FallInjury, poisoning and procedural complications——
EpistaxisRespiratory, thoracic and mediastinal disorders——
UrticariaSkin and subcutaneous tissue disorders——
Fever ≥ 38°C but ≤ 39°CGeneral disorders——
Fever > 39°C but ≤ 40°CGeneral disorders——
Fever > 40°CGeneral disorders——

Data from ClinicalTrials.gov NCT00853749 adverse events section.

Sponsor's own description

The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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