13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
27 февраля 2015 г. обновлено: Pfizer
A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
500
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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The Gambia
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Ksmd, The Gambia, Гамбия
- Fajikunda Major Health Centre
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The Gambia, West Africa
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Fajara, The Gambia, West Africa, Гамбия, 000273
- Medical Research Council Unit, The Gambia
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 1 месяц до 2 месяца (Ребенок)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Aged 42 to 70 days at enrollment.
- Determined by medical history, physical examination, and clinical judgment to be eligible for the study
- Weight of 3.5 kg or greater at the time of enrollment
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Receipt of blood products or gamma-globulin since birth
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Multidose Vial Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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Активный компаратор: Single-Dose Syringe Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Временное ограничение: 1 month after the infant series
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Временное ограничение: 1 month after the infant series
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Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Временное ограничение: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Временное ограничение: Dose 1 up to 28 to 42 days after dose 3
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
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Dose 1 up to 28 to 42 days after dose 3
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Временное ограничение: Informed consent up to Dose 1
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Adverse events were also reported in participants who provided consent but were not randomized in this study.
The data of these participants has been reported under 'Screened Only' arm.
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Informed consent up to Dose 1
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Временное ограничение: 1 month after the infant series
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Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
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1 month after the infant series
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Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Временное ограничение: 1 month after the infant series
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Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMTs were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Here "n"= participants evaluable =specified category.
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1 month after the infant series
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 января 2014 г.
Первичное завершение (Действительный)
1 сентября 2014 г.
Завершение исследования (Действительный)
1 сентября 2014 г.
Даты регистрации исследования
Первый отправленный
9 сентября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
14 октября 2013 г.
Первый опубликованный (Оценивать)
17 октября 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
13 марта 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
27 февраля 2015 г.
Последняя проверка
1 февраля 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- B4671001
- 2012-000482-21 (Номер EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .